Steritec Products, Inc.
Castle Rock, CO, US
Steritec Products, Inc. appears in FDA device records in Castle Rock, CO. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Steritec Products, Inc. between 2000 and 2026. The busiest year on record is 2000, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 4 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100) | QVB | Substantially Equivalent | |
| K083650 | EMU-GRAPH 4 EMULATOR, MODEL CI 144 | JOJ | Substantially Equivalent | |
| K080136 | INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 | JOJ | Substantially Equivalent | |
| K052516 | STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 | JOJ | Substantially Equivalent | |
| K040901 | STERITEC EMU-GRAPH, MODEL NO. CI 131/US | JOJ | Substantially Equivalent | |
| K024293 | BOWIE-DICK MINI PAK, MODEL BD 115 | JOJ | Substantially Equivalent | |
| K012732 | INTEGRAPH FLASH, MODEL CI 110 | JOJ | Substantially Equivalent | |
| K010534 | CROSS-CHECKS DUAL, MODEL CI 125 | JOJ | Substantially Equivalent | |
| K003533 | CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L | JOJ | Substantially Equivalent | |
| K003002 | STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 | JOJ | Substantially Equivalent | |
| K002861 | EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 | JOJ | Substantially Equivalent | |
| K001649 | STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 | JOJ | Substantially Equivalent | |
| K001444 | STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 | JOJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain