FDA applicant

Critical Specialties, Inc.

West Chester, PA1 decision1989–19890 recalls

FDA records 1 decision for Critical Specialties, Inc. (West Chester, PA) in 1989: 1 510(k) clearance. All are in product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)). 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 Critical Specialties, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Critical Specialties, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Critical”

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

Critical Device Corp. 6 Critical Care Systems, Inc. 1 Critical Alert 1 Critical Care Micro Computing 1 Critical Patient Care, Inc. 1 Critical Care Diagnostics, Inc. (Dba Critical Diag 1

Critical Specialties, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Critical”