510(k) Report

FDA applicant

Biodynamics Corp.

Mchenry, IL21 decisions1980–20060 recalls

FDA records 21 decisions for Biodynamics Corp. (Mchenry, IL) from 1980 to 2006: 21 510(k) clearances. Most are in product codes DSB (Plethysmograph, Impedance) and JJQ (Colorimeter, Photometer, Spectrophotometer For…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Biodynamics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biodynamics Corp. 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?

  • DSBPlethysmograph, Impedance3decisions
  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use2decisions
  • JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use2decisions
  • CACApparatus, Autotransfusion2decisions
  • CGAGlucose Oxidase, Glucose2decisions
  • KPEContainer, I.V.1decision

Also: JHS (1), JPI (1), CHI (1), GHD (1), KNK (1), MNW (1).

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K810075AutoclixBiodynamics Corp. · 19811cites it

What has FDA decided for it lately?

  • K051675Biodynamics Bia 500 Biompedance Body Composition AnalyzerBiodynamics Corp. · 2006
  • K884033Biodynamics Model 200 Body Composition AnalyzerBiodynamics Corp. · 1988
  • K881631Biodynamics Autotransfusion ReservoirBiodynamics Corp. · 1988
  • K881968Biodynamics Model BI-400 Body Composition AnalyzerBiodynamics Corp. · 1988
  • K874361Biodynamics Model BI-300 Body Composition AnalyzerBiodynamics Corp. · 1988
  • K873807Autotransfusion ApparatusBiodynamics Corp. · 1988
  • K874034Adr-22 Automatic Dialyzer ReprocessorBiodynamics Corp. · 1987
  • K870052Infumix Mixing ContainerBiodynamics Corp. · 1987

All 21 as Biodynamics Corp. →