510(k) Report

FDA applicant

Devetec, Inc.

Bradenton, FL4 decisions1985–19890 recalls

FDA records 4 decisions for Devetec, Inc. (Bradenton, FL) from 1985 to 1989: 4 510(k) clearances. Most are in product codes JTS (Stains, Microbiologic) and KFD (Aniline Blue). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Devetec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Devetec, 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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