510(k) Report

FDA applicant

Holco Instrument Corp.

Mchenry, IL2 decisions1977–19790 recalls

FDA records 2 decisions for Holco Instrument Corp. (Mchenry, IL) from 1977 to 1979: 2 510(k) clearances. Most are in product codes FSM (Tray, Surgical, Instrument) and KXA (Prosthesis, Hip, Femoral, Resurfacing). 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 Holco Instrument Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Holco Instrument Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Holco Instrument 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?

  • FSMTray, Surgical, Instrument1decision
  • KXAProsthesis, Hip, Femoral, Resurfacing1decision

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.

  • K770428Various Surg. & Diagnostic Instru. Etc.Holco Instrument Corp. · 19791cites it

What has FDA decided for it lately?

  • K770428Various Surg. & Diagnostic Instru. Etc.Holco Instrument Corp. · 1979
  • K761324Resurface Prostheses for Hip JointHolco Instrument Corp. · 1977

All 2 as Holco Instrument Corp. →