FDA applicant

Irvine Scientific

Santa Ana, CA16 decisions1982–20162 recalls

FDA records 16 decisions for Irvine Scientific (Santa Ana, CA) from 1982 to 2016: 16 510(k) clearances. Most are in product codes HDR (Cap, Cervical) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2021

2007high 2 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Irvine”

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

Irvine Scientific Sales Co., Inc. 40 Irvine Biomedical, Inc. 13 Irvine Diagnostic Services 10 Irvine Biomedical,Inc.(Ibi) 2 Irvine Biomedical, A St. Jude Medical Company 2

Irvine Scientific

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?

Other applicant names beginning “Irvine”