510(k) Report

FDA applicant

Hittman Medical Systems

Walker, MI3 decisions1979–19830 recalls

FDA records 3 decisions for Hittman Medical Systems (Walker, MI) from 1979 to 1983: 3 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Hittman Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hittman Medical Systems 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?

  • DSIDetector And Alarm, Arrhythmia2decisions
  • DPSElectrocardiograph1decision

What has FDA decided for it lately?

  • K832772Saturn-24HR. Holter ScannerHittman Medical Systems · 1983
  • K791632Compu-ScanHittman Medical Systems · 1979
  • K790300Meta IiiHittman Medical Systems · 1979

All 3 as Hittman Medical Systems →