FDA applicant

Critical Device Corp.

Brea, CA6 decisions1996–19998 recalls

FDA records 6 decisions for Critical Device Corp. (Brea, CA) from 1996 to 1999: 6 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LHI (Set, I.V. Fluid Transfer). Its devices cite 2 predicates, 0 of them its own earlier devices. 8 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, general hospital panel, where it files most

How often FDA has decided Critical Device Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Critical Device Corp. since 2007.

Recalls per year

4in 2010

2007high 4 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Critical Device Corp.’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 “Critical”

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

Critical Care Systems, Inc. 1 Critical Alert 1 Critical Care Micro Computing 1 Critical Specialties, Inc. 1 Critical Patient Care, Inc. 1 Critical Care Diagnostics, Inc. (Dba Critical Diag 1

Critical Device Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Critical”