Data / Medical devices / United States / Steritec Products MFG. Co., Inc.
Steritec Products MFG. Co., Inc.: FDA-registered device maker in Englewood, CO, United States, 22 510(k) clearances
Steritec Products MFG. Co., Inc. is registered with the FDA (registration 2028456) in Englewood, CO, United States. It lists 3 device types. The FDA files 22 510(k) clearances under its listings, the newest dated February 20, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2028456
- FEI number
- 1000125215
- Address
- 74 Inverness DR E, Englewood, CO, United States, 80112
- Owner or operator
- Getinge (9057664)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 2, 2015
- Registered through
- 2026
- Brand names listed
- CROSS-CHECKS, GETINGE ASSURE CHEMISIX PACK EMULATOR TEST PACK, GETINGE ASSURE CHEMISIX PACK EXTENDED, Getinge Assured AccuFast Biological Test Pack w/ 5 Controls, Getinge Assured AccuFast BiologicalTest Pack w/25 Controls, Getinge Assured AccuView Biological Test Pack w/ 5 Controls, Getinge Assured AccuView Biological Test Pack w/25 Controls, Getinge Assured Bowie-Dick Test Card and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Indicator, Sterilization | LRT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2025 | K250172 | Green Card Bowie-Dick Test (BD115) | JOJ | Substantially Equivalent | Steritec Products, Inc. (A Getinge Company) | accessdata.fda.gov |
| October 15, 2024 | K242795 | Getinge Assured MI Steam Migrating Integrator | JOJ | Substantially Equivalent | Steritec Products Mfg. (A Getinge Group Company) | accessdata.fda.gov |
| May 21, 2020 | K200252 | Getinge Assured MI Steam Migrating Integrator | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| August 27, 2014 | K133549 | STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| August 25, 2014 | K133322 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| November 26, 2013 | K132372 | STERITEC GREEN CARD PACK BOWIE-DICK TEST | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| July 8, 2011 | K111150 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| February 11, 2011 | K103000 | SMART READ BIOLOGICAL TEST PACK | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| March 5, 2009 | K083650 | EMU-GRAPH 4 EMULATOR, MODEL CI 144 | JOJ | Substantially Equivalent | Steritec Products, Inc. | accessdata.fda.gov |
| August 15, 2008 | K080136 | INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 | JOJ | Substantially Equivalent | Steritec Products, Inc. | accessdata.fda.gov |
| October 3, 2005 | K052516 | STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 | JOJ | Substantially Equivalent | Steritec Products, Inc. | accessdata.fda.gov |
| August 11, 2003 | K024293 | BOWIE-DICK MINI PAK, MODEL BD 115 | JOJ | Substantially Equivalent | Steritec Products, Inc. | accessdata.fda.gov |
| May 15, 2000 | K001444 | STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 | JOJ | Substantially Equivalent | Steritec Products, Inc. | accessdata.fda.gov |
| March 14, 2000 | K000502 | STEAM/EO RECORD CARD, MODEL CI 121 | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| June 10, 1999 | K990246 | STERI-PAK LF BOWIE-DICK TEST PACK | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| October 29, 1998 | K981497 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS | FRC | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| October 8, 1998 | K982547 | STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| April 23, 1998 | K965212 | STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| May 8, 1997 | K960441 | STERITEC INTEGRAPH MODEL CI-101 | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| April 2, 1997 | K953122 | STERITEC DRY HEAT INDICATOR LABEL | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| August 19, 1996 | K951113 | CROSS-CHECKS | LRT | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
| March 12, 1996 | K955426 | STERITEC CROSS-CHECKS | JOJ | Substantially Equivalent | Steritec Products Mfg Co, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 10, 2013 | 65473 | Class II | Terminated | Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator int | Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. | accessdata.fda.gov |
| July 15, 2009 | 52777 | Not yet classified | Terminated | Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238. | This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. There is insufficient data on file to support the shelf life dating on the product labeling. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Indicator, Biological Sterilization Process
Updated February 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.