510(k) Report

FDA applicant

Health Watch, Inc.

South West Ranches, FL2 decisions1992–19970 recalls

FDA records 2 decisions for Health Watch, Inc. (South West Ranches, FL) from 1992 to 1997: 2 510(k) clearances. Most are in product codes LDR (Controller, Infusion, Intravascular, Electronic) and DPS (Electrocardiograph). 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 Health Watch, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Health Watch, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LDRController, Infusion, Intravascular, Electronic1decision
  • DPSElectrocardiograph1decision

What has FDA decided for it lately?

  • K963136Pacer Model 100 Infusion ControllerHealth Watch, Inc. · 1997
  • K921331Cambridge PC/GXT Stress Test SystemHealth Watch, Inc. · 1992

All 2 as Health Watch, Inc. →