510(k) Report

FDA applicant

Avocet Medical, Inc.

San Jose, CA4 decisions1998–20000 recalls

FDA records 4 decisions for Avocet Medical, Inc. (San Jose, CA) from 1998 to 2000: 4 510(k) clearances. Most are in product codes GJS (Test, Time, Prothrombin) and JPA (System, Multipurpose For In Vitro Coagulation…). 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 Avocet Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avocet Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Avocet Medical, 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 “Avocet”

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