Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Device Facts
| Record ID | K260309 |
|---|---|
| Device Name | Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set |
| Applicant | Ambu A/S |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Sep 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Ambu® aScope™ 5 Broncho: aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel. Ambu® aScope™ 5 Broncho Sampler Set: aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel. aScope 5 Broncho Sampler Set enables aspiration and collection of fluid samples.
Device Story
Sterile, single-use flexible bronchoscope; integrated camera module with dual LED illumination; provides 400x400 pixel image signal. Used for airway/tracheobronchial tree examination; visualization via Ambu aView 2 Advance or aBox 2 display units. Working channel allows endotherapy instrument passage or fluid instillation. Sampler Set includes Bronchoscope attachment part (BAP) and containers to divert/collect aspirated fluid samples in a closed system. Operated by clinicians in clinical settings; insertion via mouth, nose, or airway tubes. Output viewed on external display; assists in diagnostic/therapeutic decision-making. Benefits include reduced cross-contamination risk due to single-use nature and expanded utility for pediatric populations.
Clinical Evidence
No clinical data. Evidence consists of bench-top verification testing (ISO 8600 series, electrical safety, EMC, biocompatibility, sterilization, shelf-life) and human factors/usability validation in pediatric models with 30 clinicians (15 intubators, 15 bronchoscopists).
Technological Characteristics
Single-use flexible bronchoscope; integrated CMOS camera (160 Kpixel sensor); dual LED illumination. Working channel for instruments/suction. Materials biocompatible per ISO 10993. Sterilized via ISO 11135. Connectivity: proprietary interface to Ambu display units (aView 2 Advance/aBox 2).
Indications for Use
Indicated for endoscopic procedures and examination of airways and tracheobronchial tree in pediatric patients (down to 6 months for 2.7/1.2 model; down to 6 years for 4.2/2.2 model) and adults. Enables visualization via compatible Ambu display units, passage of endotherapy instruments, and fluid sample collection (Sampler Set).
Regulatory Classification
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
Predicate Devices
- Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aScope™ 5 Broncho 2.7/1.2 (K233671)
- Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set (K232582)
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
September 16, 2026
Ambu A/S
% Sanjay Parikh
Senior Director, QA/RA
Ambu, Inc.
Contact Address
Re: K260309
Trade/Device Name: Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2;
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Regulation Number: 21 CFR 874.4680
Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories
Regulatory Class: Class II
Product Code: EOQ
Dated: August 17, 2026
Received: August 17, 2026
Dear Sanjay Parikh:
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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K260309 - Sanjay Parikh
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 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-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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K260309 - Sanjay Parikh
Page 3
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. | K260309 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | | |
| Please provide your Indications for Use below. | | ? |
| Ambu® aScope™ 5 Broncho: aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel. Ambu® aScope™ 5 Broncho Sampler Set: aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel. aScope 5 Broncho Sampler Set enables aspiration and collection of fluid samples. | | |
| 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) #: K260309
# 510(k) Summary
Prepared on: 2026-09-16
Contact Details
21 CFR 807.92(a)(1)
Applicant Name
Ambu A/S
Applicant Address
Baltorpbakken 13 Ballerup 2750 Denmark
Applicant Contact Telephone
+45 7225 2094
Applicant Contact
Mrs. Karina Matthiesen
Applicant Contact Email
kama@ambu.com
Correspondent Name
Ambu Inc.
Correspondent Address
6721 Columbia Gateway Drive, Suite 200 Columbia MD 21046
United States
Correspondent Contact Telephone
+1 443 831 9844
Correspondent Contact
Mr. Sanjay Parikh
Correspondent Contact Email
sap@ambu.com
Device Name
21 CFR 807.92(a)(2)
Device Trade Name
Ambu® aScope™ 5 Broncho 2.7/1.2;
Ambu® aScope™ 5 Broncho 4.2/2.2;
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Common Name
Bronchoscope (flexible or rigid) and accessories
Classification Name
Bronchoscope (Flexible Or Rigid)
Regulation Number
874.4680
Product Code(s)
EOQ
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
Predicate #
Predicate Trade Name (Primary Predicate is listed first)
Product Code
K233671
Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aScope™ 5 Broncho 2.7/1.2
EOQ
K232582
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
EOQ
Device Description Summary
21 CFR 807.92(a)(4)
Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size configurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size and size-identifying color marking, the endoscopes share a similar design. The insertion portion is inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a
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working channel system within the endoscope for use with endotherapy instruments or instillation of fluids. An introducer (Luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use; this converts the working channel port from being compatible with a syringe with luer slip connector to being compatible with a syringe with luer lock connector. Suctioning of blood, saliva, and mucus from the airways is possible through the suction system.
Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor.
Ambu® aScope™ 5 Broncho is intended to be used in combination with a compatible displaying unit, i.e., Ambu® aView™ 2 Advance or Ambu® aBox™ 2.
Ambu® aScope™ 5 Broncho Sampler Set consists of the Ambu® aScope™ 5 Broncho 4.2/2.2 endoscope as well as the following components:
- Bronchoscope attachment part (BAP)
- Two sample containers
- Suction connection tube (connects the suction connector of the BAP to a male suction adapter, if needed)
- 2 Luer lock adapters (introducers)
All of the components (including the endoscope) are packaged and sterilized together and are intended for single-use only.
The additional components of Ambu® aScope™ 5 Broncho Sampler Set augment the endoscope's functionality by allowing it to retain the fluid samples it acquires within a closed system. This function is achieved by inserting the BAP and the suction connection tube (if needed) into the suction pathway between the suction connector of the endoscope and the vacuum source (typically a regulated wall suction connection), diverting the flow of material aspirated by the endoscope to the sample container for later processing. The sample container can be removed and replaced by the user to support multiple samples being taken during the same procedure.
## Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Ambu® aScope™ 5 Broncho:
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.
Ambu® aScope™ 5 Broncho Sampler Set:
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.
aScope 5 Broncho Sampler Set enables aspiration and collection of fluid samples.
## Indications for Use Comparison
21 CFR 807.92(a)(5)
The intended use/indications for use of Ambu® aScope™ 5 Broncho and Ambu® aScope™ 5 Broncho Sampler Set are the same as those of the predicate devices.
The intended patient population has been extended. While the predicate devices are intended for adult patients only, the subject devices are also intended for pediatric patients down to 6 years of age (Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set) or 6 months of age (Ambu® aScope™ 5 Broncho 2.7/1.2). This extension of the intended patient population does not alter the intended use of the devices, which remains consistent across age groups: the subject devices continue to perform the same clinical function, in the same anatomical location, and under similar conditions as the predicate devices.
## Technological Comparison
21 CFR 807.92(a)(6)
The overall design and performance specifications of Ambu® aScope™ 5 Broncho and Ambu® aScope™ 5 Broncho Sampler Set are identical to those of the predicate devices. However, the subject devices differ from the predicates in the following aspects:
- Working channel material has been changed
- Labeling changes, including expansion of intended patient population from adults only to include children down to 6 years of age (Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set) or 6 months of age (Ambu® aScope™ 5 Broncho 2.7/1.2)
## Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Performance requirements have been evaluated in accordance with the ISO 8600 series:
- ISO 8600-1 Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements
- ISO 8600-3 Endoscopes – Medical endoscopes and endotherapy devices – Part 3: Determination of field of view and direction of view of endoscopes with optics
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• ISO 8600-4 Endoscopes – Medical endoscopes and endotherapy devices – Part 4: Determination of maximum width of insertion portion
The following tests have been performed to verify/validate the design and evaluate the performance of Ambu® aScope™ 5 Broncho and Ambu® aScope™ 5 Broncho Sampler Set:
• Verification tests including:
- Insertion portion dimensions
- Bending performance
- Suction performance
- Connectivity testing for sampling components (aScope 5 Broncho Sampler Set only)
- Duration of use
• Optical performance tests including:
- Field of view
- Direction of view
- Depth of field
- Resolution
- Color performance
- Image intensity uniformity
- Geometric distortion
• Photobiological safety in accordance with IEC 62471
• Transportation study
• Sterilization validation in accordance with ISO 11135
• Stability study to document shelf life
- Performance tests
- Sterile packaging integrity
• Biocompatibility in accordance with ISO 10993-1, including tests for:
- Cytotoxicity (ISO 10993-5)
- Irritation (ISO 10993-23)
- Sensitization (ISO 10993-10)
- Pyrogenicity (USP <151>)
- Acute Systemic Toxicity (ISO 10993-11)
• Electrical safety testing in accordance with IEC 60601-1 and IEC 60601-2-18
• Electromagnetic compatibility testing in accordance with IEC 60601-1-2
In all instances, Ambu® aScope™ 5 Broncho and Ambu® aScope™ 5 Broncho Sampler Set performed as expected and met the test specifications set.
In addition, design validation and usability testing (human factors validation) has been performed in pediatric models with 15 pediatric intubators and 15 pediatric bronchoscopists to support the extension of the intended patient population.
Clinical testing was not applicable for this 510(k).
The verification testing conducted for the subject devices, Ambu® aScope™ 5 Broncho and Ambu® aScope™ 5 Broncho Sampler Set, demonstrates that the devices meet their design specifications.
Design validation and usability testing performed in pediatric models support the extension of the indicated patient population. These evaluations verified that the devices can be used for their intended purpose in pediatric scenarios and that clinicians can operate them safely and effectively.
Overall, the results of the verification testing, design validation, and usability testing provide evidence that the subject devices are substantially equivalent to the predicate devices and are suitable for their intended use.
