510(k) Report

FDA applicant

Clinical Data Instruments, Inc.

Walker, MI3 decisions1983–19850 recalls

FDA records 3 decisions for Clinical Data Instruments, Inc. (Walker, MI) from 1983 to 1985: 3 510(k) clearances. Most are in product codes DSH (Recorder, Magnetic Tape, Medical) and IOQ (Bed, Flotation Therapy, Powered). 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 Clinical Data Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Data Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Clinical Data Instruments, 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?

  • DSHRecorder, Magnetic Tape, Medical1decision
  • IOQBed, Flotation Therapy, Powered1decision
  • DRJSystem, Signal Isolation1decision

What has FDA decided for it lately?

  • K842349Ambulatory PH Recording DeviceClinical Data Instruments, Inc. · 1985
  • K832828Centurion Cardiac DetectorClinical Data Instruments, Inc. · 1984
  • K832829Neo-Float Neonatal Flotation Sys & RhytClinical Data Instruments, Inc. · 1983

All 3 as Clinical Data Instruments, Inc. →