510(k) Report

FDA applicant

Key Medical, Inc.

Mchenry, IL4 decisions1981–19820 recalls

FDA records 4 decisions for Key Medical, Inc. (Mchenry, IL) from 1981 to 1982: 4 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GFG (Bit, Surgical). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Key Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Key Medical, 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • GFGBit, Surgical1decision
  • HAMApparatus, Electrosurgical1decision

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.

  • K810909Micro CauteryKey Medical, Inc. · 19811cites it

What has FDA decided for it lately?

  • K821127Key DrillKey Medical, Inc. · 1982
  • K812760HI-Temp Cardiovascular CauteryKey Medical, Inc. · 1982
  • K812644Replaceable Battery Perfectemp 2 CautKey Medical, Inc. · 1981
  • K810909Micro CauteryKey Medical, Inc. · 1981

All 4 as Key Medical, Inc. →