# Steritec Products Mfg Co, Inc.

- Location (FDA's records): Castle Rock, CO
- FDA decisions: 22 (1996–2020): 22 510(k) clearances
- Product codes: JOJ (16), FRC (5), LRT (1)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgicot, Inc.: 1 (https://510kreport.com/company/surgicot)
- Pymah Corp.: 1 (https://510kreport.com/company/pymah)
- STERIS Corporation: 1 (https://510kreport.com/company/steris)
- Pymah Corp., Ati Div.: 1 (https://510kreport.com/company/pymah-ati-div)
- Johnson & Johnson Medical, Inc.: 1 (https://510kreport.com/company/johnson-johnson-medical)

## Firms that cite its devices most
- STERIS Corporation: 3 (https://510kreport.com/company/steris)
- North American Science Assoc., Inc.: 1 (https://510kreport.com/company/north-american-science-assoc)
- Albert Browne, Ltd.: 1 (https://510kreport.com/company/albert-browne)
- Steritec Products Mfg. (A Getinge Group Company): 1 (https://510kreport.com/company/steritec-products-mfg-a-getinge-group)
- American Orthodontics: 1 (https://510kreport.com/company/american-orthodontics)

## Its most-cited devices
- K960441: Steritec Integraph Model CI-101 (1997), cited by 3
- K951113: Cross-Checks (1996), cited by 2
- K982188: Steri-Pak Bowie Dick Test Pack (1998), cited by 1
- K200252: Getinge Assured MI Steam Migrating Integrator (2020), cited by 1
- K000502: Steam/EO Record Card, Model CI 121 (2000), cited by 1

## Recent decisions
- 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)

Source page: https://510kreport.com/company/steritec-products-mfg