Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Steritec Products, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
206 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083650 | EMU-GRAPH 4 EMULATOR, MODEL CI 144 | Steritec Products, Inc. | 2009-03-05 | 86 | 1 |
| K080136 | INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT | Steritec Products, Inc. | 2008-08-15 | 206 | 0 |
| K052516 | STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR | Steritec Products, Inc. | 2005-10-03 | 19 | 0 |
| K040901 | STERITEC EMU-GRAPH, MODEL NO. CI 131/US | Steritec Products, Inc. | 2004-09-09 | 155 | 0 |
| K024293 | BOWIE-DICK MINI PAK, MODEL BD 115 | Steritec Products, Inc. | 2003-08-11 | 230 | 1 |
| K012732 | INTEGRAPH FLASH, MODEL CI 110 | Steritec Products, Inc. | 2002-03-04 | 200 | 0 |
| K010534 | CROSS-CHECKS DUAL, MODEL CI 125 | Steritec Products, Inc. | 2001-08-06 | 164 | 0 |
| K003533 | CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L | Steritec Products, Inc. | 2001-02-07 | 83 | 0 |
| K003002 | STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 | Steritec Products, Inc. | 2000-12-08 | 73 | 0 |
| K002861 | EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 | Steritec Products, Inc. | 2000-11-29 | 77 | 0 |
| K001649 | STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 | Steritec Products, Inc. | 2000-06-23 | 24 | 0 |
| K001444 | STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INT | Steritec Products, Inc. | 2000-05-15 | 7 | 2 |
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