Steritec Products Mfg. Co., Inc.
Englewood, CO, US
STERITEC PRODUCTS MFG. CO., INC. appears in FDA device records in Englewood, CO. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Steritec Products Mfg. Co., Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Steritec Products Mfc. Co., Inc.enforcement report, recall
510(k) clearance history
FDA records hold 22 510(k) clearances for Steritec Products Mfg. Co., Inc. between 1996 and 2020. The busiest year on record is 1998, with 5. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 4 |
| 1997 | 2 |
| 1998 | 5 |
| 1999 | 1 |
| 2000 | 1 |
| 2008 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200252 | Getinge Assured MI Steam Migrating Integrator | JOJ | Substantially Equivalent | |
| K133549 | STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | Substantially Equivalent | |
| K133322 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | Substantially Equivalent | |
| K132372 | STERITEC GREEN CARD PACK BOWIE-DICK TEST | JOJ | Substantially Equivalent | |
| K122945 | STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 | JOJ | Substantially Equivalent | |
| K122555 | STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE | JOJ | Substantially Equivalent | |
| K111150 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | Substantially Equivalent | |
| K103000 | SMART READ BIOLOGICAL TEST PACK | JOJ | Substantially Equivalent | |
| K072408 | EMU-GRAPH EMULATOR, MODEL CI 131 | JOJ | Substantially Equivalent | |
| K000502 | STEAM/EO RECORD CARD, MODEL CI 121 | JOJ | Substantially Equivalent | |
| K990246 | STERI-PAK LF BOWIE-DICK TEST PACK | JOJ | Substantially Equivalent | |
| K982188 | STERI-PAK BOWIE DICK TEST PACK | JOJ | Substantially Equivalent | |
| K981497 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS | FRC | Substantially Equivalent | |
| K982547 | STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR | JOJ | Substantially Equivalent | |
| K965212 | STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM | JOJ | Substantially Equivalent | |
| K972300 | CROSS-CHECKS P | JOJ | Substantially Equivalent | |
| K960441 | STERITEC INTEGRAPH MODEL CI-101 | JOJ | Substantially Equivalent | |
| K953122 | STERITEC DRY HEAT INDICATOR LABEL | JOJ | Substantially Equivalent | |
| K961721 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK | FRC | Substantially Equivalent | |
| K951113 | CROSS-CHECKS | LRT | Substantially Equivalent | |
| K952244 | CROSS-CHECKS EO GAS STERILIZATION MONITOR | JOJ | Substantially Equivalent | |
| K955426 | STERITEC CROSS-CHECKS | JOJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2028456 | 1000125215 | STERITEC PRODUCTS MFG. CO., INC. | 74 INVERNESS DR E, Englewood, CO 80112 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1829-2013 | Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome. | 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. | Class II | Terminated | |
| Z-1828-2013 | Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome | 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. | Class II | Terminated | |
| Z-1827-2013 | Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers. | 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. | Class II | Terminated | |
| Z-1826-2013 | Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers. | 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. | Class II | Terminated | |
| Z-1825-2013 | Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers. | 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. | Class II | Terminated | |
| Z-1824-2013 | EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. | 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. | Class II | Terminated | |
| Z-1823-2013 | Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. | 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. | Class II | Terminated | |
| Z-1822-2013 | 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 intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. | 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. | Class II | Terminated | |
| Z-1532-2010 | Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205. | This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their products. There is insufficient data on file to support the shelf life dating on the product labeling. | Terminated | ||
| Z-1531-2010 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain