510(k) Report

FDA applicant

Wolfe-Carney Medical

Salt Lake City, UT1 decision1993–19931 recall

FDA records 1 decision for Wolfe-Carney Medical (Salt Lake City, UT) in 1993: 1 510(k) clearance. All are in product code BTR (Tube, Tracheal (W/Wo Connector)). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Wolfe-Carney Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wolfe-Carney Medical since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Wolfe-Carney Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BTRTube, Tracheal (W/Wo Connector)1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K930741Esophageal Intubation DetectorWolfe-Carney Medical · 19931cites it

What has FDA decided for it lately?

  • K930741Esophageal Intubation DetectorWolfe-Carney Medical · 19931 recall

The one decision as Wolfe-Carney Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K930741LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to…May 23, 2012Class II

Other applicant names beginning “Wolfe-Carney”

FDA records each applicant name separately; these may or may not be the same firm.

Wolfe Tory Medical, Inc. 5