# 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

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Mar 28, 2018 after 113 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: 9 generations back to K921244 (1992). 25 ancestors in all.
39 later devices descend from it; 16 cite it directly.
1 of 65 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161656: Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor, Ambu A/S (2016) Summary page 4.

## Most influential descendants
- K220606: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 (2022), 10 descendants of its own
- K191828: Vathin Video Bronchoscope System (2020), 8 descendants of its own
- 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
- K210379: Broncho Videoscope System (2021), 3 descendants of its own

## Indications for use
The aScope 3 and aScope 4 Broncho endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The aScope 3 system and aScope 4 Broncho system are for use in a hospital environment. The aScope 3 and aScope 4 Broncho are single-use devices designed for use in adults. They have been evaluated for the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA) sizes: aScope 3 Slim and aScope 4 Broncho Slim: Minimum ETT inner diameter 5.0 mm; Minimum DLT size 35 Fr; EA minimum working channel width Up to 1.2 mm aScope 3 Regular and aScope 4 Broncho Regular: Minimum ETT inner diameter 6.0 mm; Minimum DLT size 41 Fr; EA minimum working channel width Up to 2.0 mm aScope 3 Large and aScope 4 Broncho Large: Minimum ETT inner diameter 7.0 mm; Minimum DLT size -; EA minimum working channel width Up to 2.6 mm

Source page: https://510kreport.com/device/K173727
Methodology: https://510kreport.com/methodology