Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Steritec Products Mfg Co, Inc. · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
185 daysmedian FDA review time
482 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200252 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg Co, Inc. | 2020-05-21 | 108 | 0 |
| K133549 | STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATO | Steritec Products Mfg Co, Inc. | 2014-08-27 | 281 | 0 |
| K133322 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOU | Steritec Products Mfg Co, Inc. | 2014-08-25 | 300 | 0 |
| K132372 | STERITEC GREEN CARD PACK BOWIE-DICK TEST | Steritec Products Mfg Co, Inc. | 2013-11-26 | 119 | 0 |
| K122945 | STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 | Steritec Products Mfg Co, Inc. | 2013-04-30 | 218 | 0 |
| K122555 | STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE | Steritec Products Mfg Co, Inc. | 2012-12-12 | 112 | 0 |
| K111150 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOU | Steritec Products Mfg Co, Inc. | 2011-07-08 | 74 | 3 |
| K103000 | SMART READ BIOLOGICAL TEST PACK | Steritec Products Mfg Co, Inc. | 2011-02-11 | 126 | 0 |
| K072408 | EMU-GRAPH EMULATOR, MODEL CI 131 | Steritec Products Mfg Co, Inc. | 2008-04-30 | 247 | 0 |
| K000502 | STEAM/EO RECORD CARD, MODEL CI 121 | Steritec Products Mfg Co, Inc. | 2000-03-14 | 28 | 0 |
| K990246 | STERI-PAK LF BOWIE-DICK TEST PACK | Steritec Products Mfg Co, Inc. | 1999-06-10 | 135 | 0 |
| K982188 | STERI-PAK BOWIE DICK TEST PACK | Steritec Products Mfg Co, Inc. | 1998-11-20 | 151 | 0 |
| K981497 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS | Steritec Products Mfg Co, Inc. | 1998-10-29 | 185 | 0 |
| K982547 | STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR | Steritec Products Mfg Co, Inc. | 1998-10-08 | 79 | 0 |
| K965212 | STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM | Steritec Products Mfg Co, Inc. | 1998-04-23 | 482 | 0 |
| K972300 | CROSS-CHECKS P | Steritec Products Mfg Co, Inc. | 1998-03-25 | 279 | 1 |
| K960441 | STERITEC INTEGRAPH MODEL CI-101 | Steritec Products Mfg Co, Inc. | 1997-05-08 | 462 | 0 |
| K953122 | STERITEC DRY HEAT INDICATOR LABEL | Steritec Products Mfg Co, Inc. | 1997-04-02 | 637 | 0 |
| K961721 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK | Steritec Products Mfg Co, Inc. | 1996-08-23 | 112 | 0 |
| K951113 | CROSS-CHECKS | Steritec Products Mfg Co, Inc. | 1996-08-19 | 528 | 0 |
| K952244 | CROSS-CHECKS EO GAS STERILIZATION MONITOR | Steritec Products Mfg Co, Inc. | 1996-08-05 | 451 | 0 |
| K955426 | STERITEC CROSS-CHECKS | Steritec Products Mfg Co, Inc. | 1996-03-12 | 105 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda