510(k) Report

FDA applicant

Clinical Technology Corp.

Rochester, NY12 decisions1982–19941 recall

FDA records 12 decisions for Clinical Technology Corp. (Rochester, NY) from 1982 to 1994: 12 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FRC (Indicator, Biological Sterilization Process). 1 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Clinical Technology Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Clinical Technology 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • FRCIndicator, Biological Sterilization Process1decision
  • LXHOrthopedic Manual Surgical Instrument1decision
  • GHMTest, Sickle Cell1decision
  • FLLContinuous Measurement Thermometer1decision
  • LFLInstrument, Ultrasonic Surgical1decision

Also: EFB (1), LBK (1), LCP (1).

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.

  • K872867BiosignClinical Technology Corp. · 19881cites it
  • K855138Bovie Ultrasonic Surgical SystemClinical Technology Corp. · 19861cites it

What has FDA decided for it lately?

  • K925080Tek-LubeClinical Technology Corp. · 1994
  • K872867BiosignClinical Technology Corp. · 1988
  • K880166Bovie Ultrasonic Surgical Aspirator, Model ME2000Clinical Technology Corp. · 1988
  • K872705Bovie 400-CT Electrosurgical Generator (Unit)Clinical Technology Corp. · 1987
  • K855138Bovie Ultrasonic Surgical SystemClinical Technology Corp. · 1986
  • K854231Electrosurgical Cutting & Coagulation Device/AccesClinical Technology Corp. · 1986
  • K853507Steri-GripClinical Technology Corp. · 1985
  • K852986Glyco-Sep/Alc Test Kit for Separat of HemoglobinClinical Technology Corp. · 1985

All 12 as Clinical Technology Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K841272Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of…Dec 16, 2005