510(k) Report

FDA applicant

Criticare Technologies Corp.

Sparks, NV1 decision1986–19860 recalls

FDA records 1 decision for Criticare Technologies Corp. (Sparks, NV) in 1986: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Criticare Technologies Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Criticare”

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