# K232582: Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

- Pathway: 510(k) (Special)
- Applicant: Ambu A/S
- Decided: Sep 20, 2023 after 26 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: 12 generations back to K921244 (1992). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230428: Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2, Ambu A/S (2023) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Apr 7, 2025 · Class II · Z-1723-2025: Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping

## Indications for use
Ambu® aScope™ 5 Broncho Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. Ambu® aScope™ 5 Broncho Sampler Set 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 enables aspiration and collection of fluid samples.

Source page: https://510kreport.com/device/K232582
Methodology: https://510kreport.com/methodology