Advanced Sterilization Products
Irvine, CA, US
ADVANCED STERILIZATION PRODUCTS appears in FDA device records in Irvine, CA. FDA records list 59 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 69 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 59FDA records hold 59 510(k) clearances for Advanced Sterilization Products between 1994 and 2026. The busiest year on record is 2012, with 8. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1999 | 3 |
| 2000 | 4 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 1 |
| 2005 | 5 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 1 |
| 2011 | 7 |
| 2012 | 8 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | MLR | Substantially Equivalent | |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) | MLR | Substantially Equivalent | |
| 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) | JOJ | Substantially Equivalent | |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) | MLR | Substantially Equivalent | |
| K220404 | STERRAD NX with ALLClear Technology | MLR | Substantially Equivalent | |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | MLR | Substantially Equivalent | |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator | KCT | Substantially Equivalent | |
| K162007 | STERRAD NX Sterilizer | MLR | Substantially Equivalent | |
| K160818 | STERRAD® NX Sterilizer with ALLClear™ Technology | MLR | Substantially Equivalent | |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | MLR | Substantially Equivalent | |
| K151725 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | MLR | Substantially Equivalent | |
| K151971 | STERRAD CYCLESURE 24 Biological Indicator | FRC | Substantially Equivalent | |
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | MLR | Substantially Equivalent | |
| K140977 | EVOTECH ECR | FEB | Substantially Equivalent | |
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | FRG | Substantially Equivalent | |
| K130263 | STERRAD 50/100S/200 TEST PACK | FRC | Substantially Equivalent | |
| K123017 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 | FRC | Substantially Equivalent | |
| K112087 | TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS | KCT | Substantially Equivalent | |
| K122044 | STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K111519 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 | JOJ | Substantially Equivalent | |
| K111518 | STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 | JOJ | Substantially Equivalent | |
| K111391 | STERRAD (R) 100NX DUO CYCLE TEST PACK | FRC | Substantially Equivalent | |
| K111375 | STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K111377 | STERRAD(R) 100NX STERILIZER DUO CYCLE | MLR | Substantially Equivalent | |
| K103210 | TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS | FRG | Substantially Equivalent | |
| K103219 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE | JOJ | Substantially Equivalent | |
| K103218 | STERRAD CHEMICAL INDICATOR STRIP | JOJ | Substantially Equivalent | |
| K092622 | STERRAD 100NX STERILIZER EXPRESS CYCLE | MLR | Substantially Equivalent | |
| K103222 | STERRAD CYCLESURE BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K092755 | STERRAAD 100NX EXPRESS CYCLE TEST PACK | FRC | Substantially Equivalent | |
| K102884 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR | FEB | Substantially Equivalent | |
| K071537 | STERRAD 100NX TEST PACK | FRC | Substantially Equivalent | |
| K071385 | STERRAD 100NX STERILIZER | MLR | Substantially Equivalent | |
| K071014 | MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K061899 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | FEB | Substantially Equivalent | |
| K051643 | STERRAD STERILIZER CYCLESURE TEST PACK | FRC | Substantially Equivalent | |
| K042450 | STERRAD NX CHALLENGE PACK | FRC | Substantially Equivalent | |
| K042116 | STERRAD NX STERILIZER | MLR | Substantially Equivalent | |
| K032959 | CIDEX OPA CONCENTRATE | MED | Substantially Equivalent | |
| K040883 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | FEB | Substantially Equivalent | |
| K040742 | MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE | JOJ | Substantially Equivalent | |
| K030429 | STERRAD 200 STERILIZER | MLR | Substantially Equivalent | |
| K031226 | STERRAD CYCLESURE BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K023290 | STERRAD 50 & STERRAD 100S STERILIZERS | FLF | Substantially Equivalent | |
| K030004 | 0.55% ORTH-PHTHALALDEHYDE SOLUTION | MED | Substantially Equivalent | |
| K022441 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE | JOJ | Substantially Equivalent | |
| K013003 | APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER | FRG | Substantially Equivalent | |
| K994055 | STERRAD CYCLESURE BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K002401 | CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) | MED | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2084725 | 3003662624 | ADVANCED STERILIZATION PRODUCTS | 33 TECHNOLOGY DRIVE, Irvine, CA 92618 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- JTQBath, Incubators/Water, All
- FLGCleaner, Ultrasonic, Medical Instrument
- FRCIndicator, Biological Sterilization Process
- JOJIndicator, Physical/Chemical Sterilization Process
- OUGMedical Device Data System
- MEDSterilant, Medical Devices
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- MLRSterilizer, Chemical
- FLFSterilizer, Ethylene-Oxide Gas
- FLESterilizer, Steam
- INWTable, Mechanical
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- SCSUltraviolet Radiation Disinfection Chamber Device
- FRGWrap, Sterilization
Recall records
Showing 25 of 69| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1197-2017 | STERRAD NX Sterilization System, Product Code: 10033, 10033-002 | Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. | Class II | Terminated | |
| Z-0965-2017 | EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60C} semi-critical endoscopes. | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak. | Class II | Terminated | |
| Z-2774-2015 | CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. | Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use). | Class II | Terminated | |
| Z-2459-2015 | CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 | Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life. | Class II | Terminated | |
| Z-2375-2015 | Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. | Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators." | Class II | Terminated | |
| Z-1715-2015 | EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes. | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. | Class II | Terminated | |
| Z-1714-2015 | EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes. | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. | Class II | Terminated | |
| Z-1312-2015 | Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 | Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013. | Class II | Terminated | |
| Z-0846-2015 | STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | Class II | Terminated | |
| Z-0845-2015 | STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | Class II | Terminated | |
| Z-0844-2015 | STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | Class II | Terminated | |
| Z-0843-2015 | STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | Class II | Terminated | |
| Z-0842-2015 | STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | Class II | Terminated | |
| Z-0746-2014 | STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments. | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. | Class II | Terminated | |
| Z-0745-2014 | STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments. | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. | Class II | Terminated | |
| Z-0744-2014 | STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments. | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. | Class II | Terminated | |
| Z-0604-2014 | STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. | Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator. | Class II | Terminated | |
| Z-0403-2014 | STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems. | Class II | Terminated | |
| Z-0402-2014 | STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems. | Class II | Terminated | |
| Z-0190-2014 | Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps. | Class II | Terminated | |
| Z-0434-2014 | STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents. | Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers. | Class III | Terminated | |
| Z-0043-2014 | 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. | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. | Class II | Terminated | |
| Z-0044-2014 | STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life. | Class II | Terminated | |
| Z-2174-2013 | STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life. | Class II | Terminated | |
| Z-1180-2013 | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. | Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain