510(k) Report

FDA applicant

Steritec Products, Inc.

Castle Rock, CO13 decisions2000–20263 recalls

FDA records 13 decisions for Steritec Products, Inc. (Castle Rock, CO) from 2000 to 2026: 13 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and QVB (Biological Sterilization Indicator With…). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Steritec Products”.

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 Steritec Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2013

2009: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Steritec Products, 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?

  • JOJIndicator, Physical/Chemical Sterilization Process12decisions
  • QVBBiological Sterilization Indicator With Indirect Growth Detection1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K002861EO Gas Sterilization Process Indicator Tapes, Model CI 124Steritec Products, Inc. · 20002cite it
  • K001444Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI 103Steritec Products, Inc. · 20002cite it
  • K080136Instant Readout Chemical Integrator Challenge Pack, Model LT- 105Steritec Products, Inc. · 20081cites it
  • K003002Sterilization Process Indicator Tapes Model CI112 & CI123Steritec Products, Inc. · 20001cites it
  • K001649Steritec Autoclave Tapes, Model CI122 & CI1234Steritec Products, Inc. · 20001cites it
  • K024293Bowie-Dick Mini Pak, Model BD 115Steritec Products, Inc. · 20031cites it

What has FDA decided for it lately?

  • K252306Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD)…Steritec Products · 2026
  • K083650Emu-Graph 4 Emulator, Model CI 144Steritec Products, Inc. · 20091 recall
  • K080136Instant Readout Chemical Integrator Challenge Pack, Model LT- 105Steritec Products, Inc. · 2008
  • K052516Steritec Container Cord - CI 135, Steritec Process Indicator Labels - CI 140, Steritec Process Indicator…Steritec Products, Inc. · 2005
  • K040901Steritec Emu-Graph, Model NO. CI 131/USSteritec Products, Inc. · 2004
  • K024293Bowie-Dick Mini Pak, Model BD 115Steritec Products, Inc. · 20031 recall
  • K012732Integraph Flash, Model CI 110Steritec Products, Inc. · 2002
  • K010534Cross-Checks Dual, Model CI 125Steritec Products, Inc. · 2001

All 12 as Steritec Products, Inc. →The one decision as Steritec Products →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K001444Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code…Jun 10, 2013Class II
  • K001444Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product…Jun 10, 2013Class II
  • K024293Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick).…Jul 15, 2009

Other applicant names beginning “Steritec”

FDA records each applicant name separately; these may or may not be the same firm.

Steritec Products Mfg Co, Inc. 22Steritec Products, Inc. (A Getinge Company) 1Steritec Products Mfg. (A Getinge Group Company) 1