ADVANCED STERILIZATION PRODUCTS

FDA Device Registration & Listing · Irvine, CA, US · Registration 2084725

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2084725
FEI Number
3003662624
Entity Name
ADVANCED STERILIZATION PRODUCTS
City/State/Country
Irvine, CA, US
Establishment Address
33 TECHNOLOGY DRIVE, Irvine, CA 92618, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Advanced Sterilization Products (Owner Number: 9068155)
Owner / Operator Contact Address
33 Technology Drive, --, Irvine, CA 92618, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K991999
PMA Number
N/A

All Registered Proprietary Names

STERRAD 100S Sterilizer and Cassette (10101, 10113) STERRAD 100NX System DUO Cycle Upgrade Kit (10144, 10104, 10104-002,003,004) STERRAD 100NX w ALLClear Technology (10144, 10104ACSW, 10104-005,-006,-007,-008) STERRAD SEALSURE Chemical Indicator (14100) STERRAD SEALSURE Chemical Indicator Tape (Non-Latex 14202NL) ASP ACCESS (53001) STERRAD NX System Cart (10300) Enzol (2252, 2257), Cidezyme (2258, 2260), Cidezyme XTRA (22591 ) AEROZYME XTRA (22520) STERRAD NX Cassette (10133) STERRAD SEALSURE Chemical Indicator (CI) Tape (14202NL) STERRAD VELOCITY Biological Indicator (BI) 60 Count (43210) STERRAD VELOCITY Reader (43220) STERRAD Chemical Indicator (CI) Strip (14100) STERRAD VELOCITY Biological Indicator (BI) 30 Count (43210-30) ULTRA GI Cycle Validation Kit (43380) ULTRA GI Process Challenge Device (PCD) Vial (43400) Incubator ASP CIDEX Plus Solution Test Strips APTIMAX Instrument Tray Holders (994XX) STERRAD VELOCITY Biological Indicator and Reader (43210, 43210-30, 43220) Tyvek Pouch/Roll with STERRAD Chemical Indicator (123XX, 124XX, 125XX) STERRAD Chemical Indicator Strip (14100) STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104-009, 10104-010) APTIMAX Instrument Tray for ULTRA GI Cycle (011077) ULTRA GI Cycle Validation Kit (43380) STERRAD SEALSURE Chemical Indicator Tape (14202) STERRAD 100NX Sterilizer and Cassette (10104, 10104-002, 10144) Tyvek Pouch/Roll with STERRAD Chemical Indicator (123XX, 124XX, 125XX) STERRAD Sterilization Pouch ( 120XX, 127XX) STERRAD Instrument Tray Mats (992XX) STERRAD NX Test Pack (20239) STERRAD 100 NX EXPRESS Test Pack (20123) STERRAD 100NX Sterilization System with ALLClear Technology (10144,10104ACSW, 10104-005,10104-006, 10104-007, 10104-008) STERRAD 100NX Test Pack Kit (20243) STERRAD Chemical Indicator Strip (14100) STERRAD VELOCITY BI/PCD (30 and 60 Count), STERRAD VELOCITY READER (43210,43220) STERRAD NX and 100NX with DTI Connectivity (DTINX, DTI100NX) EVOTECH ECR (50004) STERRAD SealSure Chemical Indicator Tape (14202) STERRAD NX Sterilization System with ALLClear Technology (10133, 10033-004, 10033ACSW) Tyvek Pouch/Roll with STERRAD Chemical Indicator (123XX, 124XX, 125XX) STERRAD 100NX System EXPRESS Cycle (10144,10104,10104-002) STERRAD 100S Sterilizer and Cassette (10101, 10113)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLF Sterilizer, Ethylene-Oxide Gas General Hospital Class 2 880.6860 2008-05-06
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2012-11-01
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2016-10-31
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2008-01-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2008-01-10
OUG Medical Device Data System General Hospital Class 1 880.6310 2017-07-19
INW Table, Mechanical Physical Medicine Class 1 890.3750 2013-02-01
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2021-02-11
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 1999-07-08
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2024-09-23
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2024-09-23
JTQ Bath, Incubators/Water, All Microbiology Class 1 866.2540 2016-03-31
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2008-05-06
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-02-01
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2017-07-18
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2017-08-21
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2017-08-21
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2012-11-01
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-09-18
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2024-09-18
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2011-11-03
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2008-01-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2012-11-01
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2012-11-01
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2008-01-10
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-02-01
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2008-01-10
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2011-11-03
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2024-10-29
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2008-01-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2011-11-03
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-02-03
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2015-04-08
FEB Accessories, Cleaning, For Endoscope Gastroenterology, Urology Class 2 876.1500 2015-04-14
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2012-11-01
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2024-10-29
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2011-11-03
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2011-11-03
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 1999-07-08

Official Correspondent

Brent Lewis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advanced Sterilization Products
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015392401 ASP Global Manufacturing GmbH SCHAFFHAUSEN, CH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142034 3M Company 3M STERI-VAC STERILIZER/AERATOR 2015-01-08
K151482 Bcr Diagnostics, Inc. BCR-30-min BI™ and RBIP-ST30™ Readout Accessory 2016-02-26
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2014 Advanced Sterilization Products 2
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0044-2014 Advanced Sterilization Products 2
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0022-2013 3M Company Health Care Business 3M Center 2
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

Similar Registrations

Registration Number Establishment Name Location
3042272797 SOLVENTUM US LLC Eagan, MN, US
3015392401 ASP Global Manufacturing GmbH SCHAFFHAUSEN, CH
2133641 BENCHMARK ELECTRONICS, INC. WINONA, MN, US
3005646850 Jabil Inc. AUBURN HILLS, MI, US
3004634710 Andersen Sterilizers, Inc. Haw River, NC, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2084725. Last updated year: 2026. Please use registration number 2084725 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.