# Advanced Sterilization Products

- Location (FDA's records): Irvin, CA
- FDA decisions: 59 (1994–2026): 59 510(k) clearances
- Names in FDA's records: Advanced Sterilization Products (54); Advanced Sterilization Products, Inc. (5)
- Product codes: MLR (17), FRC (17), JOJ (8), MED (5), FEB (4), FRG (3), KCT (3), FLE (1), FLF (1)
- 510(k) review time since 2016: median 196 days, against 183 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 67 (60 its own); citations of its devices by later devices: 93 (60 its own)
- Recalls linked to its devices: 52 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Johnson & Johnson Medical, Inc.: 4 (https://510kreport.com/company/johnson-johnson-medical)
- Medivators, Inc.: 1 (https://510kreport.com/company/medivators)
- Advanced Sterilization Products (Asp): 1 (https://510kreport.com/company/advanced-sterilization-products-asp)
- Steris C/O Medical Device Consultants, Inc.: 1 (https://510kreport.com/company/steris-c-o-medical-device-consultants)

## Firms that cite its devices most
- STERIS Corporation: 14 (https://510kreport.com/company/steris)
- Tso3, Inc.: 3 (https://510kreport.com/company/tso3)
- Advanced Sterilization Products (Asp): 2 (https://510kreport.com/company/advanced-sterilization-products-asp)
- Medivators Reprocessing Systems: 2 (https://510kreport.com/company/medivators-reprocessing-systems)
- 3M Company: 2 (https://510kreport.com/company/3m)
- Cs Medical, LLC: 1 (https://510kreport.com/company/cs-medical)
- Minntech Corp.: 1 (https://510kreport.com/company/minntech)
- Spsmedical Supply Corp. A Division of Cantel Medical: 1 (https://510kreport.com/company/spsmedical-supply-a-division-of-cantel-medical)

## Its most-cited devices
- K042116: Sterrad NX Sterilizer (2005), cited by 5
- K013003: Aptimax Instrument Tray, Instrument Mat and Instrument Holder (2002), cited by 5
- K994055: Sterrad Cyclesure Biological Indicator (2002), cited by 5
- K111377: Sterrad (R) 100NX Sterilizer Duo Cycle (2012), cited by 4
- K142454: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (2015), cited by 4
- K061899: Evotech Integrated Endoscope Disinfection System (2006), cited by 4

## Recent decisions
- K252843: STERRAD 100NX Sterilization System with ALLClear Technology (10104) (Apr 15, 2026)
- K250802: STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (Apr 14, 2025)
- K234082: STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) (Jul 5, 2024)
- K234084: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) (Jul 5, 2024)
- K220404: STERRAD NX with ALLClear Technology (May 16, 2022)
- K212174: STERRAD 100NX Sterilizer with ALLClear Technology (Oct 9, 2021)
- K163598: Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator (Jul 31, 2017)
- K162007: STERRAD NX Sterilizer (Feb 16, 2017)

Source page: https://510kreport.com/company/advanced-sterilization-products