FDA applicant

Qualtex, Inc.

Walker, MI2 decisions1978–19900 recalls

FDA records 2 decisions for Qualtex, Inc. (Walker, MI) from 1978 to 1990: 2 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and FZZ (Marker, Skin). No 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, general and plastic surgery panel, where it files most

How often FDA has decided Qualtex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Qualtex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Qualtex, Inc.

Which product codes does it file in?

What has FDA decided for it lately?