510(k) Report

FDA applicant

Medical Concepts Development, Inc.

Woodbury, MN6 decisions1986–20020 recalls

FDA records 6 decisions for Medical Concepts Development, Inc. (Woodbury, MN) from 1986 to 2002: 6 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and KGX (Tape And Bandage, Adhesive). 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 Medical Concepts Development, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Concepts Development, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Concepts Development, 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?

  • KKXDrape, Surgical, Antimicrobial3decisions
  • KGXTape And Bandage, Adhesive1decision
  • FSMTray, Surgical, Instrument1decision

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.

  • K020581Coloshield Colonoscopy Drape Model E2000Medical Concepts Development, Inc. · 20021cites it
  • K000442Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,D6651, D66XXMedical Concepts Development, Inc. · 20011cites it

What has FDA decided for it lately?

  • K020581Coloshield Colonoscopy Drape Model E2000Medical Concepts Development, Inc. · 2002
  • K000442Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,D6651, D66XXMedical Concepts Development, Inc. · 2001
  • K924794Transparent Adhesive DressingMedical Concepts Development, Inc. · 1993
  • K870044MCD Specialty Brand Needle CountersMedical Concepts Development, Inc. · 1987
  • K861530Surgical Packs, Kits and TraysMedical Concepts Development, Inc. · 1986
  • K861531Disposable Surgical Drapes and AccessoriesMedical Concepts Development, Inc. · 1986

All 6 as Medical Concepts Development, Inc. →