# K110962: Ambu Ascope 2

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Nov 18, 2011 after 226 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
67 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K090317: Babi*Plus Bubble Pap Valve, A Plus Medical (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview (2013), 64 descendants of its own
- 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

## Indications for use
The Ambu® aScope™ 2 is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non-difficult and difficult intubating procedures or for visualization of the airway during Percutaneous Tracheostomy (PT) procedures. The Ambu® aScope™ 2 achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu® aScope™ 2 is in the human anatomy. The flexible tip of the Ambu® aScope™ 2 allows the user to guide the ETT in the desired direction. The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.

Source page: https://510kreport.com/device/K110962
Methodology: https://510kreport.com/methodology