# K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Nov 1, 2013 after 220 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: 7 generations back to K921244 (1992). 23 ancestors in all.
64 later devices descend from it; 4 cite it directly.
1 of 88 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series, The Olympus Optical Co. (2003) Summary page 1.
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment, The Olympus Optical Co. (1998) Summary page 1.
- K091768: Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor & Accessories, Vision-Sciences, Inc. (2009) Summary page 1.
- K110962: Ambu Ascope 2, Ambu A/S (2011) Summary page 1.

## Most influential descendants
- 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 (2016), 40 descendants of its own
- 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
- K160766: Ambu USR, Ambu M (2016), 14 descendants of its own
- K193095: Ambu aScope 4 Cysto (2020), 13 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

## Indications for use
The aScope 3 endoscopes have been designed to be used with the aView monitor, endlotherapy accessories and other ancillary equipment for endoscopy within 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 tube' (OLT) sizes: aScope 3 Slim 3.8/1.2 5.0mm 37Fr aScope 3 5.0/2.2 6.0mm 4lFr Endoscopic accessories designed for a minimum working channel width up to 2.0mm can be used with the aScope 3-5. Endloscopic accessories designed for a minimum working channel width up to 1.2mm can be used with the aScope 3-Slim.

Source page: https://510kreport.com/device/K130845
Methodology: https://510kreport.com/methodology