510(k) Report

FDA applicant

Alpha Protech, Inc.

Salt Lake City, UT2 decisions1989–20090 recalls

FDA records 2 decisions for Alpha Protech, Inc. (Salt Lake City, UT) from 1989 to 2009: 2 510(k) clearances. Most are in product codes MSH (Respirator, Surgical) and FXX (Mask, Surgical). 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 Alpha Protech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Alpha Protech, 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 “Alpha”

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