# K093186: Ambu Ascope and Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Apr 16, 2010 after 189 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
Longest line of descent: 5 generations back to K822082 (1982). 11 ancestors in all.
No later device cites it as a predicate yet.
2 of 12 devices in its family (counting itself) have 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 3.
- K850978: Olympus LF-1 Intubation Scope, Olympus Corp. (1985) Summary page 3.
- K052233: Tracheoscopic Ventilation Tube (TVT) System, Etview, Ltd. (2005) Summary page 3.
- K090777: Ezc Medical, LLC Intubaidflex, Ezc Medical, LLC (2009) Summary page 3.

## Indications for use
The Ambu aScope 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 intubation procedures. The Ambu aScope achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu aScope is in the human anatomy. The flexible tip of the Ambu aScope 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. Topical anesthetics can be administered via a channel with a luer connector

Source page: https://510kreport.com/device/K093186
Methodology: https://510kreport.com/methodology