# K223299: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Jun 1, 2023 after 217 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921244 (1992). 40 ancestors in all.
6 later devices descend from it; 4 cite it directly.
2 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220606: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2, Ambu A/S (2022) Summary page 4.

## Most influential descendants
- 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
- 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
- K253184: Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) (2026), 0 descendants of its own
- K242416: Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL (2025), 0 descendants of its own
- K241612: Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) (2024), 0 descendants of its own

## Recalls of this device
- Dec 5, 2023 · Class II · Z-0714-2024: Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths w

## Indications for use
Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. Ambu® aScope™ 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 Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

Source page: https://510kreport.com/device/K223299
Methodology: https://510kreport.com/methodology