FDA applicant

Kentec Medical, Inc.

Irvine, CA6 decisions1985–20129 recalls

FDA records 6 decisions for Kentec Medical, Inc. (Irvine, CA) from 1985 to 2012: 6 510(k) clearances. Most are in product codes FMT (Warmer, Infant Radiant) and KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 6 predicates, 0 of them its own earlier devices. 9 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2012

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

7in 2020

2007high 7 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

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Kentec 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?