FDA applicant

Care Systems, Inc.

Huntsville, AL3 decisions1988–19910 recalls

FDA records 3 decisions for Care Systems, Inc. (Huntsville, AL) from 1988 to 1991: 3 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Care Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Care Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Care Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?