# K260309: 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

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Sep 16, 2026 after 229 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K921244 (1992). 44 ancestors in all.
No later device cites it as a predicate yet.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233671: Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance, Ambu A/S (2024) Summary page 5.
- K232582: Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set, Ambu A/S (2023) Summary page 5.

## 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 TM 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.

Source page: https://510kreport.com/device/K260309
Methodology: https://510kreport.com/methodology