510(k) Report

FDA applicant

Pacific Andrology, Inc.

Irvine, CA2 decisions1999–19990 recalls

FDA records 2 decisions for Pacific Andrology, Inc. (Irvine, CA) in 1999: 2 510(k) clearances. Most are in product codes MQH (Microtools, Assisted Reproduction (Pipettes)) and MQL (Media, Reproductive). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Pacific Andrology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pacific Andrology, 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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