510(k) Report

FDA applicant

Clinicomp, Inc.

Mchenry, IL3 decisions1984–19950 recalls

FDA records 3 decisions for Clinicomp, Inc. (Mchenry, IL) from 1984 to 1995: 3 510(k) clearances. Most are in product codes KPT (Calibrator, Dose, Radionuclide) and HGM (System, Monitoring, Perinatal). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Clinicomp, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Clinicomp, 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?

  • KPTCalibrator, Dose, Radionuclide2decisions
  • HGMSystem, Monitoring, Perinatal1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K931133Clinical Infor Syst (Cis) W/Fetal Monit Remote DispClinicomp, Inc. · 19952cite it

What has FDA decided for it lately?

  • K931133Clinical Infor Syst (Cis) W/Fetal Monit Remote DispClinicomp, Inc. · 1995
  • K850838Clinicomp RDMS Radionuclide Dispensing MGMT. SoftwClinicomp, Inc. · 1985
  • K842540Clinicomp R.C.I.Clinicomp, Inc. · 1984

All 3 as Clinicomp, Inc. →

Other applicant names beginning “Clinicomp”

FDA records each applicant name separately; these may or may not be the same firm.

CliniComp, Intl. 1