Steritec Products Mfg Co, Inc.
FDA Regulatory Profile
Steritec Products Mfg Co, Inc. has 0 FDA recalls, 6 inspections, 22 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Jul 13, 2026 · NAI
- Latest 510(k)
- May 21, 2020
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 22 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 13, 2026 | Englewood, CO | Devices | No Action Indicated (NAI) | 1000125215 |
| Dec 1, 2022 | Englewood, CO | Devices | No Action Indicated (NAI) | 1000125215 |
| Feb 1, 2017 | Englewood, CO | Devices | Voluntary Action Indicated (VAI) | 1000125215 |
| May 1, 2013 | Englewood, CO | Devices | No Action Indicated (NAI) | 1000125215 |
| Aug 12, 2010 | Englewood, CO | Devices | No Action Indicated (NAI) | 1000125215 |
| Jun 2, 2009 | Englewood, CO | Devices | Official Action Indicated (OAI) | 1000125215 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1000125215 | Englewood, CO | 6 | Jul 13, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200252 | Getinge Assured MI Steam Migrating Integrator | May 21, 2020 |
| K133549 | STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | Aug 27, 2014 |
| K133322 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | Aug 25, 2014 |
| K132372 | STERITEC GREEN CARD PACK BOWIE-DICK TEST | Nov 26, 2013 |
| K122945 | STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 | Apr 30, 2013 |
| K122555 | STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE | Dec 12, 2012 |
| K111150 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | Jul 8, 2011 |
| K103000 | SMART READ BIOLOGICAL TEST PACK | Feb 11, 2011 |
| K072408 | EMU-GRAPH EMULATOR, MODEL CI 131 | Apr 30, 2008 |
| K000502 | STEAM/EO RECORD CARD, MODEL CI 121 | Mar 14, 2000 |
| K990246 | STERI-PAK LF BOWIE-DICK TEST PACK | Jun 10, 1999 |
| K982188 | STERI-PAK BOWIE DICK TEST PACK | Nov 20, 1998 |
| K981497 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS | Oct 29, 1998 |
| K982547 | STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR | Oct 8, 1998 |
| K965212 | STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM | Apr 23, 1998 |
| K972300 | CROSS-CHECKS P | Mar 25, 1998 |
| K960441 | STERITEC INTEGRAPH MODEL CI-101 | May 8, 1997 |
| K953122 | STERITEC DRY HEAT INDICATOR LABEL | Apr 2, 1997 |
| K961721 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK | Aug 23, 1996 |
| K951113 | CROSS-CHECKS | Aug 19, 1996 |