FDA applicant

Harbor Medtech, Inc.

Irvine, CA2 decisions2013–20140 recalls

FDA records 2 decisions for Harbor Medtech, Inc. (Irvine, CA) from 2013 to 2014: 2 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

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

FDA decisions per year

1in 2014

2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Harbor Medtech, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Harbor Medtech, 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

Other applicant names beginning “Harbor”

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

Harbor Medical Devices, Inc. 7 Harbor Medical, Inc. 2

Harbor Medtech, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Harbor”