510(k) Report

FDA applicant

R. Wolf Medical Instruments Corp.

Mchenry, IL2 decisions1981–19820 recalls

FDA records 2 decisions for R. Wolf Medical Instruments Corp. (Mchenry, IL) from 1981 to 1982: 2 510(k) clearances. Most are in product codes KCP (Syringe, Ent) and FFK (Lithotriptor, Electro-Hydraulic). 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, ear, nose and throat panel, where it files most

How often FDA has decided R. Wolf Medical Instruments Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R. Wolf Medical Instruments Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R. Wolf Medical Instruments 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?

  • KCPSyringe, Ent1decision
  • FFKLithotriptor, Electro-Hydraulic1decision

What has FDA decided for it lately?

  • K822644Riwolith 2135R. Wolf Medical Instruments Corp. · 1982
  • K810284Automatic Teflon Injection SyringeR. Wolf Medical Instruments Corp. · 1981

All 2 as R. Wolf Medical Instruments Corp. →