510(k) Report

FDA applicant

Surgikos, Inc.

Mchenry, IL56 decisions1976–19881 recall

FDA records 56 decisions for Surgikos, Inc. (Mchenry, IL) from 1976 to 1988: 56 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FYA (Gown, Surgical). 1 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 Surgikos, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgikos, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Surgikos, 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, Antimicrobial30decisions
  • FYAGown, Surgical5decisions
  • FXXMask, Surgical2decisions
  • FXYHood, Surgical2decisions
  • KGOSurgeon'S Gloves2decisions
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2decisions

Also: FYF (1), DTL (1), CAK (1), KRI (1), HOY (1), BZQ (1).

Who builds on its devices?

Later devices cite its devices 13 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.

  • K760937Barrier Neuro SheetSurgikos, Inc. · 19761cites it
  • K780843Barrier Abdominal Pack Fabric 450Surgikos, Inc. · 19781cites it
  • K780839Barrier Pediatric/Incise Drape 450Surgikos, Inc. · 19781cites it
  • K760902Barrier Under Buttocks DrapeSurgikos, Inc. · 19761cites it
  • K760933Barrier Universal SheetSurgikos, Inc. · 19761cites it
  • K780841Barrier Medium Sheet 450Surgikos, Inc. · 19781cites it

What has FDA decided for it lately?

  • K875107Health Care Eye ProtectionSurgikos, Inc. · 1988
  • K874653Sterile Surgical Scrub BrushSurgikos, Inc. · 1987
  • K861441Neutralon Surgical GlovesSurgikos, Inc. · 1986
  • K852870Barrier Surgical GownSurgikos, Inc. · 1985
  • K822535Cidex*Dialyzer Disinfecting SolutionSurgikos, Inc. · 1982
  • K820543Barrier Antimicrobial Incise DrapeSurgikos, Inc. · 1982
  • K820542Surgikos Incise DrapeSurgikos, Inc. · 1982
  • K811871Bactericidal Incise DrapeSurgikos, Inc. · 1981

All 56 as Surgikos, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K780282Barrier Hip Sheet with Side PocketsJul 14, 2003