# K981891: Ambu Tubecheck

- Pathway: 510(k) (Traditional)
- Applicant: Ambu, Inc.
- Decided: Jul 17, 1998 after 49 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. lts purpose is not to eliminate clinical judgement. To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.

Source page: https://510kreport.com/device/K981891
Methodology: https://510kreport.com/methodology