# K220606: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Jul 25, 2022 after 145 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: 10 generations back to K921244 (1992). 39 ancestors in all.
10 later devices descend from it; 3 cite it directly.
2 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173727: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor, Ambu A/S (2018) Summary page 4.
- K061313: Evis Exera 180 System, Olympus Medical Systems Corporation (2006) Summary page 4.

## Most influential descendants
- K223299: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (2023), 6 descendants of its own
- K230428: Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 (2023), 4 descendants of its own
- K233671: Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance (2024), 2 descendants of its own
- K232582: Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set (2023), 1 descendant of its own
- 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 (2026), 0 descendants of its own

## Indications for use
Ambu@ aScopeTm 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. Ambu@ aScopeTm 5 Broncho HD is intended to provide visualization via a compatible Ambu@ displaying unit, and to allow passing endotherapy instruments via its working channel. The aBoxTM 2 is intended to display live imaging data from compatible Ambu visualization devices

Source page: https://510kreport.com/device/K220606
Methodology: https://510kreport.com/methodology