Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
Device Facts
| Record ID | K260134 |
|---|---|
| Device Name | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) |
| Applicant | Shenzhen Root Innovation Technology Co., Ltd. |
| Product Code | BTA · General, Plastic Surgery |
| Decision Date | May 15, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The BN006 series (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02) is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. The BN008 series (BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. The additional spray function helps moisturize and soften nasal secretions in children (over 3 years old), making them easier to aspirate.
Device Story
Electrically powered, portable nasal aspirator; battery-operated motor pump generates negative pressure to remove nasal secretions. BN008 series includes an integrated atomizer module for nasal spray function. Components include silicone nozzles (conical, flat, or angled), collection cup, air tube, and aspirator body. Operated by user (parent/caregiver) in home environment via buttons and LED display. Provides suction to clear nasal passages; spray function softens mucus to facilitate aspiration. Benefits include improved nasal hygiene and relief from congestion in pediatric patients.
Clinical Evidence
Bench testing only. Performance data includes vacuum pressure, flow rate, noise level, tubing resistance, and spray capacity. Biocompatibility testing per ISO 10993-5, -10, and -23. Electrical safety and EMC testing per IEC 60601-1, -1-2, and -1-11. Battery safety per IEC 62133-2.
Technological Characteristics
Materials: ABS, PS, Silicone. Sensing/Actuation: DC motor pump (3.7V). Energy: Rechargeable Li-ion battery (2500-2600mAh). Form factor: Portable handheld unit. Connectivity: None. Sterilization: Not specified. Software: Basic documentation level, embedded firmware for device control (buttons/LEDs).
Indications for Use
Indicated for intermittent removal of nasal secretions and mucus in children aged 2-12 years in a home environment. The spray function (BN008 series) is indicated for children over 3 years old to moisturize and soften secretions.
Regulatory Classification
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Predicate Devices
- Electric Nasal Aspirator (K244033)
- Nasal Aspirator (NS13) (K241852)
- DeVilbiss Model 6305D Heavy Duty AC Aspirator (K981602)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 15, 2026
Shenzhen Root Innovation Technology Co., Ltd.
Haiyan Wen
Compliance Engineer
#2-201, Floor 2 Hasee Computer Bldg.
#2 Beier Rd., Bantian St., Longgang
Shenzhen, Guangdong 518219
China
Re: K260134
Trade/Device Name: Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
Regulation Number: 21 CFR 878.4780
Regulation Name: Powered Suction Pump
Regulatory Class: Class II
Product Code: BTA, KMA
Dated: January 16, 2026
Received: January 16, 2026
Dear Haiyan Wen:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260134 - Haiyan Wen
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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-
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K260134 - Haiyan Wen
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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).
Sincerely,
JOYCE C. LIN -S
for Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT 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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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260134 | ? |
| Please provide the device trade name(s). | | ? |
| Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) | | |
| Please provide your Indications for Use below. | | ? |
| The BN006 series (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02) is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. The BN008 series (BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. The additional spray function helps moisturize and soften nasal secretions in children (over 3 years old), making them easier to aspirate. | | |
| Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: 2026-5-12
I. Submitter
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Building, No. 2 Beier Rd, Bantian Street, Longgang, Shenzhen, 518129, China.
Post code: 518109
Tel.: 86-755-89698173
Mr. Haiyan Wen
E-mail: wendy.wen@rootglobal.net
II. Device
Device Trade Name: Baby Nasal Aspirator
Model(s): BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021
Regulation Name: Powered Suction Pump
Regulatory Class: II
Regulation Number: 878.4780
Product Code(s): BTA, KMA
III. Predicate Device and Reference Device
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) Product | Product Code |
| --- | --- | --- |
| K244033 | Electric Nasal Aspirator | BTA |
| K241852 | Nasal Aspirator (NS13) | BTA, KMA |
| K981602 | DeVilbiss Model 6305D Heavy Duty AC Aspirator | BTA |
IV. Device Description
The Baby Nasal Aspirator is an electrically powered nasal aspirator. There are two product series: the Baby Nasal Aspirator BN006 series (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02) and the Baby Nasal Aspirator BN008 series (BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021). The main differences between the BN006 series and the BN008 series are as follows:
1) The BN006 series does not include the spray function.
2) The BN008 series is equipped with a spray function.
The BN006 series (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02) consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body.
The BN008 series (BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) consists of silicone nozzle which has two models (conical nozzle, flat nozzle) host, air tube and mucus collector. The Atomizer Module is used for moistening the nasal cavity.
The Baby Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12
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years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line.
The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button. Different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
## V. Indication for Use
The BN006 series (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02) is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.
The BN008 series (BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. The additional spray function helps moisturize and soften nasal secretions in children (over 3 years old), making them easier to aspirate.
## VI. Comparison of Technological Characteristics with the Predicate Device
The subject devices have the same intended use as the Primary predicate device and Reference Device 1. The technological characteristics such as vacuum pressure is similar as the Reference Device 2 device. The technological characteristics such as music function and light function are similar as the Primary predicate device. Any minor differences between the subject device and the listed predicate device do not raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use.
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| Comparison Element | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Remark |
| --- | --- | --- | --- | --- | --- |
| 510(k) Number | Pending | K244033 | K241852 | K981602 | \ |
| Trade name | Baby Nasal Aspirator | Electric Nasal Aspirator | Nasal Aspirator (NS13) | DeVilbiss Model 6305D Heavy Duty AC Aspirator | \ |
| Regulation number | 21 CFR § 878.4780 | 21 CFR § 878.4780 | 21 CFR § 878.4780 | 21 CFR § 878.4780 | Same |
| Product code | BTA KMA | BTA | BTA KMA | BTA | Same |
| Device classification | Class II | Class II | Class II | Class II | Same |
| Indication for use/ Intended use | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02: The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021: The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. The additional spray function helps moisturize and soften nasal secretions in children (over 3 years old), making them easier to aspirate. | The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment | The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment. The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate. | The DeVilbiss Model 630SD Heavy Duty AC Aspirator provides a vacuum source for home health care or institutional use. The product is used with a suction catheter or handle to clear secretions from the oral, nasal and pulmonary area. The intended target population for this device consists of both adult and pediatric patients. The intended environment for use of the product is in the patient's home or within an institutional setting on the order of a physician. | Same as the Primary Predicate Device and Reference Device 1 |
| Model | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021 | NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610 | NS13 | 6305D | \ |
| Patient Population | Age 2-12 years old; spray function is intended for children over 3 years old | Age 2-12 years old | Age 2-12 years old; spray function is intended for children over 3 years old | Adult and pediatric patients | Same |
| Vacuum pressure | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02: 66 Kpa (±4 Kpa) BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021: 72 Kpa (±3 Kpa) | 52-60Kpa | 100-120 mmHg | 22.0 in. Hg (equal to 75 kPa) | Similar to the Reference Device 2 |
| Spray Capacity | 0.2~0.3 ml/6sec | \ | 0.4~0.5 ml/10sec | \ | Similar to the Reference Device 1 |
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| Music function | Yes | Yes | \ | \ | Same as the Primary Predicate Device |
| --- | --- | --- | --- | --- | --- |
| Light function | Yes | Yes | \ | \ | Same as the Primary Predicate Device |
| Power consumption | 5W | 5W | \ | \ | Same as the Primary Predicate Device |
| Motor Type | 3.7V DC | 3.7V DC | \ | \ | Same as the Primary Predicate Device |
| Power Source | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02: DC 3.7 V / 2600mAh Rechargeable Li-ion battery BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021: DC 3.7 V / 2500mAh Rechargeable Li-ion battery | DC 3.7 V / 2500mAh Rechargeable Li-ion battery | \ | \ | Similar to the Primary Predicate Device |
| Device Dimension | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02: 105mm *75mm*51mm BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021: 126mm*70mm*127 mm | W95 x H45mm | \ | \ | Different Note 1 |
| Weight | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02: 276g BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021: 480±5g | 235g | Approx.158g (Exclude batteries) | \ | |
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| Tips Dimension (ψ) | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; Conical nozzle: OD 4.0 / ID 2.0 mm Flat nozzle/Angled nozzle OD 4.0 / ID 2.0 mm BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021; Conical nozzle: OD 3.5 / ID 3.0 mm Flat nozzle: OD 3.0 / ID 2.0 mm | Flat nozzle/Angled nozzle: OD 4.0 / ID 2.0 mm Conical nozzle: OD 4.0 / ID 2.0 mm | Gourd shape tip: Φ5xΦ2.6x35.68 Long tip: Φ5xΦ3x35.68 Short tip: Φ5.68xΦ3x27.68 | \ | Similar to the Primary Predicate Device |
| --- | --- | --- | --- | --- | --- |
| Main Materials | ABS, PS, Silicone | ABS, PS, Silicone | \ | \ | Same as the Primary Predicate Device |
| Operating condition | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; Temperature: 5°C(41°F) to 40°C(104°F) Humidity: 15% to 93% R.H. Atmospheric pressure: 700-1060hPa BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021; Temperature: 5°C(41°F) to 40°C(104°F) Humidity: 15% to 85% R.H. Atmospheric pressure: 700-1060hPa | Temperature: 5°C(41°F) to 40°C(104°F) Humidity: 15% to 93% R.H. Atmospheric pressure: 700-1060hPa | Temperature: 16°C ~ 35°C (60.8°F ~ 95°F) Humidity: 15%~85% RH | \ | Similar to the Primary Predicate Device |
| Storage condition | BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; Temperature: -10°C(-23°F) to 70°C (158°F) Humidity: 10% to 95% R.H. Atmospheric pressure: 700-1060hPa BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021; Temperature: 5°C(41°F) to 40°C(104°F) Humidity: 15% to 85% R.H. Atmospheric pressure: 700-1060hPa | Temperature: -10°C(-23°F) to 70°C (158°F) Humidity: 10% to 95% R.H. Atmospheric pressure: 700-1060hPa | Temperature: - 25°C ~ 55°C (-13°F ~ 131°F) Humidity: 15% to 85% R.H. | \ | Similar to the Primary Predicate Device |
| Expected service life | 2 years | 2 years | \ | \ | Same as the Primary Predicate Device |
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| Standard of Biocompatibility | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-11 ISO 10993-23 | \ | Same as Primary Predicate Device |
| --- | --- | --- | --- | --- | --- |
| Safety | IEC 60601-1 IEC 60601-1-6 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-11 | \ | Same as Primary Predicate Device |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | \ | Same as Primary Predicate Device |
## VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
### 1) Biocompatibility Testing
The biocompatibility evaluation for the patient-contacting components was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices–Part 1: Evaluation and Testing Within a Risk Management Process", as follows:
- ISO 10993-5:2009, Biological evaluation of medical devices–Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021, Biological evaluation of medical devices–Part 10: Tests for skin sensitization
- ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation
### 2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances Requirements and tests
- IEC 60601-1-11 Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance –Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
### 3) Battery Safety
- IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications -Part 2: Lithium systems
### 4) Software Verification and Validation
Software documentation consistent with basic documentation level was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels
### 5) Bench testing
Appearance Test: In order to assure the physical/visual verification of Electric Nasal Aspirator, we have conducted the product appearance test (color, dimension etc.).
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Performance Test: In order to verify and assure the performance of Electric Nasal Aspirator, we have conducted the product performance test (vacuum pressure, noise level, flow rate, tubing bending resistance, Spray Capacity, Tips Dimension etc.).
## Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Electric Nasal Aspirator is as safe, as effective, and performs as well as the legally marketed predicate device.
