510(k) Report

FDA applicant

Surgicot, Inc.

Mchenry, IL19 decisions1977–19976 recalls

FDA records 19 decisions for Surgicot, Inc. (Mchenry, IL) from 1977 to 1997: 19 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and FRC (Indicator, Biological Sterilization Process). 6 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 hospital panel, where it files most

How often FDA has decided Surgicot, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgicot, Inc. since 2007.

Recalls per year

4in 2026

2013: 12022: 12026 (partial year): 4
2007high 4 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Surgicot, 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?

  • FRGWrap, Sterilization5decisions
  • FRCIndicator, Biological Sterilization Process5decisions
  • BZAConnector, Airway (Extension)2decisions
  • BZOSet, Tubing And Support, Ventilator (W Harness)1decision
  • FLGCleaner, Ultrasonic, Medical Instrument1decision
  • HOZSponge, Ophthalmic1decision

Also: GDY (1), FZZ (1), BYP (1), ILO (1).

Who builds on its devices?

Later devices cite its devices 7 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.

  • K855101Assert TM Biological/Chemical IndicatorSurgicot, Inc. · 19863cite it
  • K771032Pouches, Peel Open, BreathableSurgicot, Inc. · 19772cite it
  • K820302Surgipeel Self-Seal Packaging SystemSurgicot, Inc. · 19821cites it
  • K800029Surgicot 2 Indicator SystemSurgicot, Inc. · 19801cites it

What has FDA decided for it lately?

  • K962605Pro-Guard Double-Duty Sterilization Wrap (Single Use)Surgicot, Inc. · 1997
  • K931270Surgiclean Enzymatic Instrument CleanerSurgicot, Inc. · 1994
  • K863122Assert Biological/Chemical Indicator 12 Month Exp.Surgicot, Inc. · 1986
  • K855101Assert TM Biological/Chemical IndicatorSurgicot, Inc. · 1986
  • K854631Assert EO Biological Test PackSurgicot, Inc. · 19861 recall
  • K854902Surgicot Steam Test PackSurgicot, Inc. · 19866 recalls
  • K840541Neuro SpongeSurgicot, Inc. · 1984
  • K840471Eye SpearSurgicot, Inc. · 1984

All 19 as Surgicot, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K854902VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007Aug 31, 2026Class II
  • K854902VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006Aug 31, 2026Class II
  • K854902VERIFY Biological Steam Test Pack Model/Catalog Number: S3069Aug 31, 2026Class II
  • K854902VERIFY Biological Steam Test Pack Model/Catalog Number: S3065Aug 31, 2026Class II
  • K070461a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch…May 25, 2022Class III
  • K083665VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS…Sep 10, 2013Class II