# 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

- Pathway: 510(k) (Special)
- Applicant: Ambu A/S
- Decided: Sep 1, 2016 after 77 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: 8 generations back to K921244 (1992). 24 ancestors in all.
40 later devices descend from it; 1 cites 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)
- K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview, Ambu A/S (2013) Summary page 4.

## Most influential descendants
- 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 (2018), 39 descendants of its own
- 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

## Indications for use
The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree. The aScope 3 system is for use in a hospital environment. The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes: Minimum ETT inner diameter Minimum DLT size aScope 3 Slim 3.8/1.2 5.0 mm 37Fr aScope 3 Regular 5.0/2.2 6.0 mm 41 Fr aScope 3 Large 5.8/2.8 7.0 mm - Endoscopic accessories designed for a minimum working channel width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2. Endoscopic accessories designed for a minimum working channel width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2. Endoscopic accessories designed for a minimum working channel width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.

Source page: https://510kreport.com/device/K161656
Methodology: https://510kreport.com/methodology