510(k) Report

FDA applicant

Medikmark, Inc.

Chicago, IL8 decisions1992–19953 recalls

FDA records 8 decisions for Medikmark, Inc. (Chicago, IL) from 1992 to 1995: 8 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and KOH (Instrument, Manual, General…). 3 recalls are 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 Medikmark, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medikmark, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medikmark, 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
  • KOHInstrument, Manual, General Obstetric-Gynecologic2decisions
  • FRGWrap, Sterilization1decision
  • FPASet, Administration, Intravascular1decision
  • JOHTube Tracheostomy And Tube Cuff1decision

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.

  • K920341Laceration TraysMedikmark, Inc. · 19921cites it

What has FDA decided for it lately?

  • K953474IV Start KitMedikmark, Inc. · 1995
  • K923960Upper Extermity Drape KitMedikmark, Inc. · 1994
  • K921732Minor Lap SetMedikmark, Inc. · 1994
  • K921733Tracheostomy Care TrayMedikmark, Inc. · 1994
  • K921730C-Section PackMedikmark, Inc. · 1994
  • K920339Dressing Change TrayMedikmark, Inc. · 1992
  • K920340Suture Removal KitMedikmark, Inc. · 19923 recalls
  • K920341Laceration TraysMedikmark, Inc. · 1992

All 8 as Medikmark, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K920340Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover…Jul 12, 2004
  • K920340MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit…Jul 12, 2004
  • K920340Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a…Jul 12, 2004