FDA applicant

Wolfe Tory Medical, Inc.

Salt Lake City, UT5 decisions1994–20028 recalls

FDA records 5 decisions for Wolfe Tory Medical, Inc. (Salt Lake City, UT) from 1994 to 2002: 5 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and CCT (Applicator (Laryngo-Tracheal), Topical…). Its devices cite 4 predicates, 1 of them its own earlier devices. 8 recalls are 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 Tory Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wolfe Tory Medical, Inc. since 2007.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Wolfe Tory Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Wolfe”

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

Wolfe-Carney Medical 1

Wolfe Tory Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Wolfe”