# K990556: Esophageal Intubation Detector

- Pathway: 510(k) (Traditional)
- Applicant: Wolfe Tory Medical, Inc.
- Decided: Mar 26, 1999 after 32 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: 1 generation back to K930741 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942628: Esophageal Intubation Detector Bulb, Wolfe Tory Medical, Inc. (1994) Summary page 1.
- K930741: Esophageal Intubation Detector, Wolfe-Carney Medical (1993) Summary page 1.

## Indications for use
To assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube.

Source page: https://510kreport.com/device/K990556
Methodology: https://510kreport.com/methodology