510(k) Report

FDA applicant

The Oec Group

Mchenry, IL3 decisions1981–19830 recalls

FDA records 3 decisions for The Oec Group (Mchenry, IL) from 1981 to 1983: 3 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). 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 The Oec Group’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Oec Group since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Oec Group by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like The Oec Group’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KKXDrape, Surgical, Antimicrobial1decision
  • KWLProsthesis, Hip, Hemi-, Femoral, Metal1decision
  • ITIWheelchair, Powered1decision

What has FDA decided for it lately?

  • K831420Hip Prosthesis -VariousThe Oec Group · 1983
  • K830723Redi-DrapeThe Oec Group · 1983
  • K811656Powered WheelchairThe Oec Group · 1981

All 3 as The Oec Group →