AllNEB
Device Facts
| Record ID | K242354 |
|---|---|
| Device Name | AllNEB |
| Applicant | Enchant Tek Co. , Ltd. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Apr 29, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.
Device Story
AllNEB is a pneumatic jet nebulizer for delivering aerosolized medication to patients. It connects to an external compressed air or oxygen source. Operation involves gas passing through a central orifice, creating negative pressure that draws liquid medication to the nozzle; the gas flow shears the liquid into an aerosol. The device features a mode selector for either breath-actuated delivery (only during patient inspiration) or continuous mode. Breath-actuation reduces fugitive emissions. Used in homes, hospitals, and clinics by patients or caregivers. Output is inhaled aerosolized medication, which facilitates respiratory treatment. The device is single-patient, multiple-use, and non-sterile.
Clinical Evidence
Bench testing only. Performance evaluated via comparative aerosol testing (MMAD, GSD, total dose, respirable dose, fine/coarse/ultra-fine particle doses) using Albuterol Sulfate, Ipratropium Bromide, and Cromolyn Sodium at 5 and 8 lpm flow rates. Testing included both adult and pediatric simulated breathing patterns. Results demonstrate performance substantially equivalent to the predicate.
Technological Characteristics
Pneumatic jet nebulizer; gas-driven (air/oxygen). Materials meet ISO 10993-1 and ISO 18562-1 for permanent mucosal/tissue contact. Flow rate 5–8 lpm; 6ml max fill volume. Breath-actuated or continuous mode selector. Non-sterile, single-patient, multiple-use device.
Indications for Use
Indicated for adults and pediatric patients >5 years old under medical care for administration of prescribed aerosolized medication.
Regulatory Classification
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Predicate Devices
- AeroEclipse II Breath Actuated Nebulizer (K053605)
Related Devices
- K200063 — AeroEclipse* ONE BAN · Trudell Medical International · Jul 17, 2020
- K150591 — Besmed Reusable Jet Nebulizer · Besmed Health Business Corp · Jun 30, 2015
- K123527 — AIRLIFE · Care Fusion · Apr 25, 2013
- K080969 — HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 · Medi Nuclear Corp., Inc. · Jul 25, 2008
- K173825 — MC 300R* Nebulizer · Trudell Medical International · May 2, 2018
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
April 29, 2025
Enchant Tek Co. Ltd.
% Paul Dryden
President
ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg, Florida 33704
Re: K242354
Trade/Device Name: AllNEB
Regulation Number: 21 CFR 868.5630
Regulation Name: Nebulizer
Regulatory Class: Class II
Product Code: CAF
Dated: April 1, 2025
Received: April 1, 2025
Dear Paul Dryden:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K242354 - Paul Dryden
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K242354 - Paul Dryden
Page 3
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K242354 | |
| Device Name AllNEB Breath Actuated Nebulizer | |
| Indications for Use (Describe) AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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K242354
510(k) Summary
Page 1 of 12
Date Prepared: 29-Apr-25
Sponsor: Enchant Tek Co. Ltd.
No. 210 Xiangzhong Rd.
Dongshan Township, Yilan County
Taipei, TW 26950
Tel +886- 03-959-3500
Sponsor Contact: Ling Leonard – QA/RA Supervisor
Submission Correspondent: Paul Dryden
ProMedic, LLC
Proprietary or Trade Name: AllNEB
Common/Usual Name: Nebulizer
Classification Name: Nebulizer (direct patient interface)
21CFR 868.5630
Product Code: CAF
Predicate Device: AeroEclipse II Breath Actuated Nebulizer – K053605
Common/Usual Name: Nebulizer
Classification Name: Nebulizer (direct patient interface)
21CFR 868.5630
Product Code: CAF
Device Description: AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.
Principle of Operation: The gas orifice is located in the center of the nebulizer. The driving gas (air or oxygen) passes through the small orifice and is deflected by a baffle on the actuator. The high velocity jet of gas produces a negative pressure behind it, which draws liquid up to the nozzle area. The deflected gas flow shears off the liquid being drawn up which generates the aerosol
Indications for Use:
AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.
Patient Population:
Pediatrics (5 years and older) to Adults.
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K242354
510(k) Summary
Page 2 of 12
# Environments of use:
Home, hospitals, and clinics.
| | Subject Device
AllNEB – K242354 | Predicate Device
AeroEclipse II Breath Actuated Nebulizer - K053605 | Comment |
| --- | --- | --- | --- |
| Manufacturer | Enchant | Trudell Medical International | |
| Prescriptive | Rx | Rx | Similar |
| Classification | 21 CFR 868.5630 - CAF
Nebulizer - Direct patient interface | 21 CFR 868.5630 - CAF
Nebulizer - Direct patient interface | Similar |
| Indications for use | AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics. | The AeroEclipse® II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics. | The predicate device does not disclose the patient age range. |
| Intended Use Environment | Home or in hospitals and clinics | Home or in hospitals and clinics | Similar |
| Principle of Operation | Pneumatic Jet Nebulizer | Pneumatic Jet Nebulizer | Similar |
| Aerosolization Mode | Built-in mode selector for breath actuated or continuous mode | Built-in mode selector for breath actuated or continuous mode | Similar |
| Single Patient Use | Yes | Yes | Similar |
| Type of Device | Single patient use, multiple use, prescription only, non-sterile | Single patient use, multiple use, prescription only, non-sterile | Similar |
| Type of gas source | Compressed air or oxygen | Compressed air or oxygen | Similar |
| Flow Rate | 5 – 8 lpm (liters per minute) | 2.75 – 8 lpm (liters per minute) | Similar |
| Maximum Fill Volume | 6ml | 6ml | Similar |
| Basic Components | BAN with Mouthpiece, Oxygen Tubing | BAN with Mouthpiece, Oxygen Tubing | Similar
Oxygen tubing is user supplied |
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K242354
510(k) Summary
Page 3 of 12
| | Subject Device
AIINEB – K242354 | Predicate Device
AeroEclipse II Breath Actuated Nebulizer - K053605 | Comment |
| --- | --- | --- | --- |
| Biocompatibility | Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent Duration ISO 10993-1 and ISO 18562-1 | Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent Duration | Similar |
| | Subject Device
AIINEB - 242354 | | | Predicate Device
AeroEclipse II Breath Actuated Nebulizer - K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Comparative Performance | | | | | | | |
| Breath Actuated Mode – Adult settings | | | | | | | |
| MMAD | Albuterol Sulfate | 5 lpm
1.51 | 8 lpm
2.03 | Albuterol Sulfate | 5 lpm
2.03 | 8 lpm
2.23 | Similar |
| | Ipratropium Bromide | 1.47 | 1.90 | Ipratropium Bromide | 1.93 | 2.23 | Similar |
| | Cromolyn Sodium | 1.50 | 1.87 | Cromolyn Sodium | 2.00 | 2.07 | Similar |
| GSD | Albuterol Sulfate | 5 lpm
2.43 | 8 lpm
1.67 | Albuterol Sulfate | 5 lpm
1.70 | 8 lpm
1.63 | Similar |
| | Ipratropium Bromide | 2.13 | 1.67 | Ipratropium Bromide | 1.67 | 1.70 | Similar |
| | Cromolyn Sodium | 2.29 | 1.70 | Cromolyn Sodium | 1.70 | 1.73 | Similar |
| Total Dose Delivered | Albuterol Sulfate | 5 lpm
1,228 | 8 lpm
1,293 | Albuterol Sulfate | 5 lpm
1,367 | 8 lpm
1,474 | Similar |
| | Ipratropium Bromide | 188 | 208 | Ipratropium Bromide | 203 | 242 | Similar |
| | Cromolyn Sodium | 5,255 | 5,781 | Cromolyn Sodium | 5,868 | 6,505 | Similar |
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K242354
510(k) Summary
Page 4 of 12
| | Subject Device AllNEB - K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Total Respirable Dose (0.5-5 um) | Albuterol Sulfate | 5 lpm 834 | 8 lpm 862 | Albuterol Sulfate | 5 lpm 847 | 8 lpm 899 | Similar |
| | Ipratropium Bromide | 129 | 136 | Ipratropium Bromide | 132 | 138 | Similar |
| | Cromolyn Sodium | 3,635 | 4,070 | Cromolyn Sodium | 3,681 | 4,030 | Similar |
| Coarse Particle Dose (>4.7 um) | Albuterol Sulfate | 5 lpm 218 | 8 lpm 258 | Albuterol Sulfate | 5 lpm 350 | 8 lpm 426 | Similar |
| | Ipratropium Bromide | 30 | 43 | Ipratropium Bromide | 48 | 76 | Similar |
| | Cromolyn Sodium | 868 | 904 | Cromolyn Sodium | 1,411 | 1,549 | Similar |
| Fine Particle Dose (<4.7 um) | Albuterol Sulfate | 5 lpm 1,010 | 8 lpm 1,035 | Albuterol Sulfate | 5 lpm 1,017 | 8 lpm 1,048 | Similar |
| | Ipratropium Bromide | 158 | 165 | Ipratropium Bromide | 155 | 167 | Similar |
| | Cromolyn Sodium | 4,388 | 4,877 | Cromolyn Sodium | 4,456 | 4,957 | Similar |
| Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate | 5 lpm 397 | 8 lpm 317 | Albuterol Sulfate | 5 lpm 307 | 8 lpm 275 | Similar |
| | Ipratropium Bromide | 62 | 52 | Ipratropium Bromide | 50 | 52 | Similar |
| | Cromolyn Sodium | 1,704 | 1,463 | Cromolyn Sodium | 1,369 | 1,501 | Similar |
| Constant-Output Mode – Adult settings Adult settings | | | | | | | |
| MMAD | Albuterol Sulfate | 5 lpm 1.46 | 8 lpm 2.06 | Albuterol Sulfate | 5 lpm 2.07 | 8 lpm 2.20 | Similar |
| | Ipratropium Bromide | 1.51 | 2.06 | Ipratropium Bromide | 1.93 | 2.10 | Similar |
| | Cromolyn Sodium | 1.52 | 2.03 | Cromolyn Sodium | 1.97 | 2.30 | Similar |
| GSD | Albuterol Sulfate | 5 lpm 2.04 | 8 lpm 1.62 | Albuterol Sulfate | 5 lpm 1.63 | 8 lpm 1.63 | Similar |
| | Ipratropium Bromide | 2.56 | 1.62 | Ipratropium Bromide | 1.67 | 1.67 | Similar |
| | Cromolyn Sodium | 2.24 | 1.67 | Cromolyn Sodium | 1.63 | 1.67 | Similar |
| Total Dose | Albuterol Sulfate | 5 lpm 1,232 | 8 lpm 1,367 | Albuterol Sulfate | 5 lpm 1,376 | 8 lpm 1,463 | Similar |
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K242354
510(k) Summary
Page 5 of 12
| | Subject Device AllNEB - K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Delivered | Ipratropium Bromide | 193 | 219 | Ipratropium Bromide | 200 | 248 | Similar |
| | Cromolyn Sodium | 5,246 | 5,674 | Cromolyn Sodium | 5,783 | 6,339 | Similar |
| Total Respirable Dose (0.5-5 um) | Albuterol Sulfate | 5 lpm 846 | 8 lpm 957 | Albuterol Sulfate | 5 lpm 880 | 8 lpm 871 | Similar |
| | Ipratropium Bromide | 132 | 152 | Ipratropium Bromide | 126 | 150 | Similar |
| | Cromolyn Sodium | 3,687 | 3,787 | Cromolyn Sodium | 3,672 | 3,845 | Similar |
| Coarse Particle Dose (>4.7 um) | Albuterol Sulfate | 5 lpm 208 | 8 lpm 256 | Albuterol Sulfate | 5 lpm 341 | 8 lpm 446 | Similar |
| | Ipratropium Bromide | 35 | 41 | Ipratropium Bromide | 48 | 68 | Similar |
| | Cromolyn Sodium | 832 | 1,127 | Cromolyn Sodium | 1,450 | 1,831 | Similar |
| Fine Particle Dose (<4.7 um) | Albuterol Sulfate | 5 lpm 1,025 | 8 lpm 1,111 | Albuterol Sulfate | 5 lpm 1,036 | 8 lpm 1,017 | Similar |
| | Ipratropium Bromide | 158 | 178 | Ipratropium Bromide | 152 | 180 | Similar |
| | Cromolyn Sodium | 4,415 | 4,547 | Cromolyn Sodium | 4,332 | 4,508 | Similar |
| Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate | 5 lpm 402 | 8 lpm 299 | Albuterol Sulfate | 5 lpm 303 | 8 lpm 284 | Similar |
| | Ipratropium Bromide | 62 | 49 | Ipratropium Bromide | 46 | 52 | Similar |
| | Cromolyn Sodium | 1,661 | 1,340 | Cromolyn Sodium | 1,399 | 1,247 | Similar |
| Breath Actuated Mode – Pediatric settings | | | | | | | |
| MMAD | Albuterol Sulfate | 5 lpm 1.37 | 8 lpm 2.19 | Albuterol Sulfate | 5 lpm 1.93 | 8 lpm 2.87 | Similar |
| | Ipratropium Bromide | 1.39 | 2.24 | Ipratropium Bromide | 1.67 | 2.93 | Similar |
| | Cromolyn Sodium | 1.32 | 2.12 | Cromolyn Sodium | 1.60 | 3.10 | Similar |
| GSD | Albuterol Sulfate | 5 lpm 1.54 | 8 lpm 1.94 | Albuterol Sulfate | 5 lpm 2.57 | 8 lpm 1.97 | Similar |
| | Ipratropium Bromide | 1.52 | 1.96 | Ipratropium Bromide | 2.93 | 2.00 | Similar |
| | Cromolyn Sodium | 1.40 | 1.94 | Cromolyn Sodium | 2.17 | 2.13 | Similar |
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K242354
510(k) Summary
Page 6 of 12
| | Subject Device AllNEB K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer -K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Total Dose Delivered | Albuterol Sulfate | 5 lpm 1347.3 | 8 lpm 1193 | Albuterol Sulfate | 5 lpm 1709.4 | 8 lpm 1515 | Similar |
| | Ipratropium Bromide | 210.9 | 196 | Ipratropium Bromide | 250.7 | 245 | Similar |
| | Cromolyn Sodium | 5436.7 | 5124 | Cromolyn Sodium | 6340.4 | 6474 | Similar |
| Total Respirable Dose (0.5-5 um) | Albuterol Sulfate | 5 lpm 892.2 | 8 lpm 805 | Albuterol Sulfate | 5 lpm 927.4 | 8 lpm 795 | Similar |
| | Ipratropium Bromide | 140.5 | 132 | Ipratropium Bromide | 137.4 | 128 | Similar |
| | Cromolyn Sodium | 3675.5 | 3595 | Cromolyn Sodium | 3657.4 | 3468 | Similar |
| Coarse Particle Dose (>4.7 um) | Albuterol Sulfate | 5 lpm 266.1 | 8 lpm 234 | Albuterol Sulfate | 5 lpm 595.5 | 8 lpm 570 | Similar |
| | Ipratropium Bromide | 41.6 | 38 | Ipratropium Bromide | 84.2 | 95 | Similar |
| | Cromolyn Sodium | 916.3 | 833 | Cromolyn Sodium | 1907.3 | 2326 | Similar |
| Fine Particle Dose (<4.7 um) | Albuterol Sulfate | 5 lpm 1081.2 | 8 lpm 959 | Albuterol Sulfate | 5 lpm 1114.0 | 8 lpm 945 | Similar |
| | Ipratropium Bromide | 169.3 | 157 | Ipratropium Bromide | 166.5 | 150 | Similar |
| | Cromolyn Sodium | 4520.4 | 4291 | Cromolyn Sodium | 4432.7 | 4148 | Similar |
| Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate | 5 lpm 334.5 | 8 lpm 217 | Albuterol Sulfate | 5 lpm 348.0 | 8 lpm 205 | Similar |
| | Ipratropium Bromide | 47.7 | 37 | Ipratropium Bromide | 50.4 | 35 | Similar |
| | Cromolyn Sodium | 1457.3 | 996 | Cromolyn Sodium | 1292.0 | 962 | Similar |
| Constant-Output Mode – Pediatric settings | | | | | | | |
| MMAD | Albuterol Sulfate | 5 lpm 1.39 | 8 lpm 2.20 | Albuterol Sulfate | 5 lpm 1.70 | 8 lpm 2.77 | Similar |
| | Ipratropium Bromide | 1.37 | 2.24 | Ipratropium Bromide | 1.97 | 2.77 | Similar |
| | Cromolyn Sodium | 1.38 | 2.33 | Cromolyn Sodium | 1.77 | 2.73 | Similar |
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K242354
510(k) Summary
Page 7 of 12
| | Subject Device AllNEB K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer -K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| GSD | Albuterol Sulfate | 5 lpm 1.91 | 8 lpm 1.97 | Albuterol Sulfate | 5 lpm 3.17 | 8 lpm 2.10 | Similar |
| | Ipratropium Bromide | 1.72 | 1.96 | Ipratropium Bromide | 2.70 | 2.10 | Similar |
| | Cromolyn Sodium | 1.50 | 1.96 | Cromolyn Sodium | 2.67 | 2.03 | Similar |
| Total Dose Delivered | Albuterol Sulfate | 5 lpm 1316 | 8 lpm 1171 | Albuterol Sulfate | 5 lpm 1651 | 8 lpm 1441 | Similar |
| | Ipratropium Bromide | 200 | 183 | Ipratropium Bromide | 256 | 233 | Similar |
| | Cromolyn Sodium | 5734 | 5255 | Cromolyn Sodium | 6654 | 6789 | Similar |
| Total Respirable | Albuterol Sulfate | 5 lpm 886 | 8 lpm 807 | Albuterol Sulfate | 5 lpm 897 | 8 lpm 731 | Similar |
| Dose (0.5-5 um) | Ipratropium Bromide | 136 | 125 | Ipratropium Bromide | 133 | 126 | Similar |
| | Cromolyn Sodium | 3862 | 3670 | Cromolyn Sodium | 3698 | 3624 | Similar |
| Coarse Particle Dose (>4.7 um) | Albuterol Sulfate | 5 lpm 250 | 8 lpm 220 | Albuterol Sulfate | 5 lpm 577 | 8 lpm 556 | Similar |
| | Ipratropium Bromide | 36 | 36 | Ipratropium Bromide | 94 | 81 | Similar |
| | Cromolyn Sodium | 1021 | 921 | Cromolyn Sodium | 2180 | 2450 | Similar |
| Fine Particle Dose (<4.7 um) | Albuterol Sulfate | 5 lpm 1067 | 8 lpm 952 | Albuterol Sulfate | 5 lpm 1074 | 8 lpm 885 | Similar |
| | Ipratropium Bromide | 164 | 146 | Ipratropium Bromide | 161 | 152 | Similar |
| | Cromolyn Sodium | 4713 | 4334 | Cromolyn Sodium | 4475 | 4339 | Similar |
| Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate | 5 lpm 313 | 8 lpm 216 | Albuterol Sulfate | 5 lpm 313 | 8 lpm 232 | Similar |
| | Ipratropium Bromide | 48 | 31 | Ipratropium Bromide | 48 | 38 | Similar |
| | Cromolyn Sodium | 1393 | 926 | Cromolyn Sodium | 1229 | 1044 | Similar |
{11}
K242354
510(k) Summary
Page 8 of 12
| | Subject Device AllNEB K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Simulated Breathing Comparison | | | | | | | |
| Breath Actuated Mode Simulated Breathing – Adult settings | | | | | | | |
| MMAD | Albuterol Sulfate | 5 lpm
1.51 | 8 lpm
2.03 | Albuterol Sulfate | 5 lpm
2.03 | 8 lpm
2.23 | Similar |
| | Ipratropium
Bromide | 1.47 | 1.90 | Ipratropium
Bromide | 1.93 | 2.23 | Similar |
| | Cromolyn
Sodium | 1.50 | 1.87 | Cromolyn
Sodium | 2.00 | 2.07 | Similar |
| GSD | Albuterol Sulfate | 5 lpm
2.43 | 8 lpm
1.67 | Albuterol Sulfate | 5 lpm
1.70 | 8 lpm
1.63 | Similar |
| | Ipratropium
Bromide | 2.13 | 1.67 | Ipratropium
Bromide | 1.67 | 1.70 | Similar |
| | Cromolyn
Sodium | 2.29 | 1.70 | Cromolyn
Sodium | 1.70 | 1.73 | Similar |
| Total Dose
Delivered | Albuterol Sulfate | 5 lpm
982 | 8 lpm
946 | Albuterol Sulfate | 5 lpm
1,074 | 8 lpm
1,092 | Similar |
| | Ipratropium
Bromide | 149 | 159 | Ipratropium
Bromide | 155 | 181 | Similar |
| | Cromolyn
Sodium | 4,130 | 4,488 | | 4,668 | 4,959 | Similar |
| Total Respirable | Albuterol Sulfate | 5 lpm
668 | 8 lpm
632 | Albuterol Sulfate | 5 lpm
665 | 8 lpm
666 | Similar |
| Dose (0.5-5 um) | Ipratropium
Bromide | 103 | 104 | Ipratropium
Bromide | 101 | 103 | Similar |
| | Cromolyn
Sodium | 2,860 | 3,159 | Cromolyn
Sodium | 2,922 | 3,076 | Similar |
| Coarse
Particle Dose
(>4.7 um) | Albuterol Sulfate | 5 lpm
173 | 8 lpm
189 | Albuterol Sulfate | 5 lpm
275 | 8 lpm
315 | Similar |
| | Ipratropium
Bromide | 24 | 33 | Ipratropium
Bromide | 36 | 56 | Similar |
| | Cromolyn
Sodium | 678 | 701 | Cromolyn
Sodium | 1,130 | 1,179 | Similar |
| Fine Particle
Dose (<4.7 um) | Albuterol Sulfate | 5 lpm
809 | 8 lpm
757 | Albuterol Sulfate | 5 lpm
799 | 8 lpm
777 | Similar |
| | Ipratropium
Bromide | 125 | 126 | Ipratropium
Bromide | 119 | 124 | Similar |
| | Cromolyn
Sodium | 3,451 | 3,787 | Cromolyn
Sodium | 3,538 | 3,781 | Similar |
{12}
K242354
510(k) Summary
Page 9 of 12
| | Subject Device AllNEB K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate | 5 lpm 319 | 8 lpm 231 | Albuterol Sulfate | 5 lpm 242 | 8 lpm 204 | Similar |
| | Ipratropium Bromide | 49 | 40 | Ipratropium Bromide | 38 | 39 | Similar |
| | Cromolyn Sodium | 1,337 | 1,138 | Cromolyn Sodium | 1,085 | 1,150 | Similar |
| Constant-Output Mode Simulated Breathing – Adult settings | | | | | | | |
| MMAD | Albuterol Sulfate | 5 lpm 1.46 | 8 lpm 2.06 | Albuterol Sulfate | 5 lpm 2.07 | 8 lpm 2.20 | Similar |
| | Ipratropium Bromide | 1.51 | 2.06 | Ipratropium Bromide | 1.93 | 2.10 | Similar |
| | Cromolyn Sodium | 1.52 | 2.03 | Cromolyn Sodium | 1.97 | 2.30 | Similar |
| GSD | Albuterol Sulfate | 5 lpm 2.04 | 8 lpm 1.62 | Albuterol Sulfate | 5 lpm 1.63 | 8 lpm 1.63 | Similar |
| | Ipratropium Bromide | 2.56 | 1.62 | Ipratropium Bromide | 1.67 | 1.67 | Similar |
| | Cromolyn Sodium | 2.24 | 1.67 | Cromolyn Sodium | 1.63 | 1.67 | Similar |
| Total Dose Delivered | Albuterol Sulfate | 5 lpm 517 | 8 lpm 570 | Albuterol Sulfate | 5 lpm 560 | 8 lpm 601 | Similar |
| | Ipratropium Bromide | 83 | 89 | Ipratropium Bromide | 85 | 106 | Similar |
| | Cromolyn Sodium | 2,297 | 2,346 | | 2,439 | 2,619 | Similar |
| Total Respirable | Albuterol Sulfate | 5 lpm 355 | 8 lpm 399 | Albuterol Sulfate | 5 lpm 357 | 8 lpm 357 | Similar |
| Dose (0.5-5 um) | Ipratropium Bromide | 57 | 61 | Ipratropium Bromide | 54 | 64 | Similar |
| | Cromolyn Sodium | 1,616 | 1,567 | Cromolyn Sodium | 1,550 | 1,589 | Similar |
| Coarse Particle Dose (>4.7 um) | Albuterol Sulfate | 5 lpm 87 | 8 lpm 106 | Albuterol Sulfate | 5 lpm 139 | 8 lpm 184 | Similar |
| | Ipratropium Bromide | 15 | 17 | Ipratropium Bromide | 21 | 29 | Similar |
| | Cromolyn Sodium | 362 | 465 | Cromolyn Sodium | 612 | 758 | Similar |
{13}
K242354
510(k) Summary
Page 10 of 12
| | Subject Device AllNEB K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Fine Particle Dose (<4.7 um) | Albuterol Sulfate | 5 lpm 430 | 8 lpm 463 | Albuterol Sulfate | 5 lpm 421 | 8 lpm 417 | Similar |
| | Ipratropium Bromide | 68 | 72 | Ipratropium Bromide | 65 | 77 | Similar |
| | Cromolyn Sodium | 1,935 | 1,881 | Cromolyn Sodium | 1,827 | 1,861 | Similar |
| Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate | 5 lpm 169 | 8 lpm 125 | Albuterol Sulfate | 5 lpm 124 | 8 lpm 117 | Similar |
| | Ipratropium Bromide | 26 | 20 | Ipratropium Bromide | 20 | 22 | Similar |
| | Cromolyn Sodium | 729 | 555 | Cromolyn Sodium | 589 | 513 | Similar |
| Breath Actuated Mode Simulated Breathing – Pediatric settings | | | | | | | |
| MMAD | Albuterol Sulfate | 5 lpm 1.37 | 8 lpm 2.19 | Albuterol Sulfate | 5 lpm 1.93 | 8 lpm 2.87 | Similar |
| | Ipratropium Bromide | 1.39 | 2.24 | Ipratropium Bromide | 1.67 | 2.93 | Similar |
| | Cromolyn Sodium | 1.32 | 2.12 | Cromolyn Sodium | 1.60 | 3.10 | Similar |
| GSD | Albuterol Sulfate | 5 lpm 1.54 | 8 lpm 1.94 | Albuterol Sulfate | 5 lpm 2.57 | 8 lpm 1.97 | Similar |
| | Ipratropium Bromide | 1.52 | 1.96 | Ipratropium Bromide | 2.93 | 2.00 | Similar |
| | Cromolyn Sodium | 1.40 | 1.94 | Cromolyn Sodium | 2.17 | 2.13 | Similar |
| Total Dose Delivered | Albuterol Sulfate | 5 lpm 1059.0 | 8 lpm 937 | Albuterol Sulfate | 5 lpm 1190.1 | 8 lpm 1,040 | Similar |
| | Ipratropium Bromide | 166.7 | 153 | Ipratropium Bromide | 184.9 | 186 | Similar |
| | Cromolyn Sodium | 4288.9 | 4,171 | Cromolyn Sodium | 5152.0 | 4,954 | Similar |
| Total Respirable Dose (0.5-5 um) | Albuterol Sulfate | 5 lpm 703.2 | 8 lpm 632 | Albuterol Sulfate | 5 lpm 645.8 | 8 lpm 548 | Similar |
{14}
K242354
510(k) Summary
Page 11 of 12
| | Subject Device AllNEB - K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Ipratropium Bromide | 111.1 | 103 | Ipratropium Bromide | 101.1 | 97 | Similar |
| | Cromolyn Sodium | 2898.6 | 2,931 | Cromolyn Sodium | 2969.6 | 2,649 | Similar |
| Coarse Particle Dose (>4.7 um) | Albuterol Sulfate | 5 lpm 207.5 | 8 lpm 183 | Albuterol Sulfate | 5 lpm 414.9 | 8 lpm 389 | Similar |
| | Ipratropium Bromide | 32.7 | 30 | Ipratropium Bromide | 62.4 | 72 | Similar |
| | Cromolyn Sodium | 723.1 | 673 | Cromolyn Sodium | 1551.7 | 1786 | Similar |
| Fine Particle Dose (<4.7 um) | Albuterol Sulfate | 5 lpm 851.5 | 8 lpm 754 | Albuterol Sulfate | 5 lpm 775.3 | 8 lpm 651 | Similar |
| | Ipratropium Bromide | 134.0 | 123 | Ipratropium Bromide | 122.5 | 114 | Similar |
| | Cromolyn Sodium | 3565.8 | 3,498 | Cromolyn Sodium | 3600.3 | 3,168 | Similar |
| Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate | 5 lpm 262.8 | 8 lpm 171 | Albuterol Sulfate | 5 lpm 241.8 | 8 lpm 141 | Similar |
| | Ipratropium Bromide | 37.7 | 29 | Ipratropium Bromide | 37.0 | 26 | Similar |
| | Cromolyn Sodium | 1151.2 | 810 | Cromolyn Sodium | 1051.7 | 735 | Similar |
| Constant-Output Mode Simulated Breathing – Pediatric settings | | | | | | | |
| MMAD | Albuterol Sulfate | 5 lpm 1.39 | 8 lpm 2.20 | Albuterol Sulfate | 5 lpm 1.70 | 8 lpm 2.77 | Similar |
| | Ipratropium Bromide | 1.37 | 2.24 | Ipratropium Bromide | 1.97 | 2.77 | Similar |
| | Cromolyn Sodium | 1.38 | 2.33 | Cromolyn Sodium | 1.77 | 2.73 | Similar |
| GSD | Albuterol Sulfate | 5 lpm 1.91 | 8 lpm 1.97 | Albuterol Sulfate | 5 lpm 3.17 | 8 lpm 2.10 | Similar |
| | Ipratropium Bromide | 1.72 | 1.96 | Ipratropium Bromide | 2.70 | 2.10 | Similar |
| | Cromolyn Sodium | 1.50 | 1.96 | Cromolyn Sodium | 2.67 | 2.03 | Similar |
{15}
K242354
510(k) Summary
Page 12 of 12
| | Subject Device AllNEB - K242354 | | | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | | | Comment |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Total Dose Delivered | Albuterol Sulfate | 5 lpm 526 | 8 lpm 463 | Albuterol Sulfate | 5 lpm 592 | 8 lpm 534 | Similar |
| | Ipratropium Bromide | 80 | 72 | Ipratropium Bromide | 96 | 79 | Similar |
| | Cromolyn Sodium | 2351 | 1970 | | 2561 | 2348 | Similar |
| Total Respirable | Albuterol Sulfate | 5 lpm 355 | 8 lpm 319 | Albuterol Sulfate | 5 lpm 321 | 8 lpm 271 | Similar |
| Dose (0.5-5 um) | Ipratropium Bromide | 54 | 50 | Similar | 50 | 43 | Similar |
| | Cromolyn Sodium | 1583 | 1376 | Similar | 1426 | 1254 | Similar |
| Coarse Particle Dose (>4.7 um) | Albuterol Sulfate | 5 lpm 99 | 8 lpm 87 | Similar | 5 lpm 207 | 8 lpm 206 | Similar |
| | Ipratropium Bromide | 15 | 14 | Ipratropium Bromide | 36 | 27 | Similar |
| | Cromolyn Sodium | 418 | 346 | Cromolyn Sodium | 838 | 846 | Similar |
| Fine Particle Dose (<4.7 um) | Albuterol Sulfate | 5 lpm 427 | 8 lpm 377 | Albuterol Sulfate | 5 lpm 385 | 8 lpm 328 | Similar |
| | Ipratropium Bromide | 66 | 58 | Ipratropium Bromide | 61 | 52 | Similar |
| | Cromolyn Sodium | 1933 | 1625 | Cromolyn Sodium | 1723 | 1502 | Similar |
| Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate | 5 lpm 125 | 8 lpm 85 | Albuterol Sulfate | 5 lpm 112 | 8 lpm 86 | Similar |
| | Ipratropium Bromide | 19 | 12 | Ipratropium Bromide | 18 | 13 | Similar |
| | Cromolyn Sodium | 572 | 348 | Cromolyn Sodium | 471 | 361 | Similar |
## Discussion of Differences
The subject device differs in the following ways from the predicate:
The predicate device does not specify an age range.
## Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and non-clinical testing that the subject device and predicate have been found to be substantially equivalent.
