Sterilizer, Chemical
FDA product code MLR · Class II (moderate risk) · 21 CFR 880.6860 · General Hospital
47510(k) clearances
0PMA approvals
41recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104)MLR · Traditional | Advanced Sterilization Products, Inc. | 04/15/2026SE |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104)MLR · Traditional | Advanced Sterilization Products, Inc. | 04/14/2025SE |
| K231893 | LOWTEM Crystal 120MLR · Traditional | Lowtem Co., Ltd. | 09/18/2024SE |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104)…MLR · Traditional | Advanced Sterilization Products | 07/05/2024SE |
| K233762 | SteroScope® Sterilization Technology SystemMLR · Traditional | Ideate Medical, Inc. | 06/27/2024SE |
| K233065 | V-PRO maX 2 Low Temperature Sterilization SystemMLR · Special | Steris | 10/20/2023SE |
| K223476 | V-PRO maX 2 Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 08/07/2023SE |
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…MLR · Special | Plasmapp Co,., Ltd. | 05/25/2023SE |
| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassetteMLR · Traditional | Plasmapp Co,., Ltd. | 05/09/2023SE |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…MLR · Traditional | Plasmapp Co,., Ltd. | 04/14/2023SE |
| K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature…MLR · Special | Steris | 09/09/2022SE |
| K220404 | STERRAD NX with ALLClear TechnologyMLR · Traditional | Advanced Sterilization Products, Inc. | 05/16/2022SE |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassetteMLR · Traditional | Plasmapp Co,., Ltd. | 10/22/2021SE |
| K212174 | STERRAD 100NX Sterilizer with ALLClear TechnologyMLR · Traditional | Advanced Sterilization Products, Inc. | 10/09/2021SE |
| K190005 | Sterilucent HC 80TT Hydrogen Peroxide SterilizerMLR · Traditional | Sterilucent, Inc. | 09/13/2019SE |
| K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization…MLR · Special | STERIS Corporation | 05/09/2019SE |
| K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature…MLR · Special | STERIS Corporation | 04/05/2019SE |
| K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization…MLR · Traditional | STERIS Corporation | 01/03/2019SE |
| K172754 | V-PRO maX 2 Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 02/09/2018SE |
| K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature…MLR · Traditional | STERIS Corporation | 01/18/2018SE |
| K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature…MLR · Traditional | STERIS Corporation | 03/31/2017SE |
| K162007 | STERRAD NX SterilizerMLR · Special | Advanced Sterilization Products | 02/16/2017SE |
| K160818 | STERRAD® NX Sterilizer with ALLClear TechnologyMLR · Traditional | Advanced Sterilization Products | 09/27/2016SE |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLR · Traditional | Advanced Sterilization Products | 09/26/2016SE |
| K160433 | V-PRO® 1 Plus and V-PRO® maX Low TemperatureMLR · Traditional | STERIS Corporation | 07/06/2016SE |
| K151725 | STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLR · Traditional | Advanced Sterilization Products | 01/13/2016SE |
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLR · Traditional | Advanced Sterilization Products | 04/03/2015SE |
| K140464 | Sterilucent PSD-85 Hydrogen Peroxide SterilizerMLR · Traditional | Sterilucent, Inc. | 10/31/2014SE |
| K140498 | V-Pro 60 Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 07/24/2014SE |
| K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 07/16/2013SE |
| K111377 | Sterrad(R) 100NX Sterilizer Duo CycleMLR · Traditional | Advanced Sterilization Products | 09/13/2012SE |
| K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 06/26/2012SE |
| K112813 | Amsco V-ProMLR · Special | Steris Corp | 12/01/2011SE |
| K112760 | Amsco V-Pro Max Low Temperature Sterilization SystemMLR · Special | STERIS Corporation | 11/22/2011SE |
| K111810 | Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization UnitsMLR · Special | STERIS Corporation | 09/02/2011SE |
| K102394 | Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low Temperature…MLR · Traditional | STERIS Corporation | 08/18/2011SE |
| K102330 | Amsco V-Pro Max Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 08/12/2011SE |
| K092622 | Sterrad 100NX Sterilizer Express CycleMLR · Traditional | Advanced Sterilization Products | 03/04/2011SE |
| K083097 | Amsco V-Pro 1 Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 08/03/2009SE |
| K071385 | Sterrad 100NX SterilizerMLR · Traditional | Advanced Sterilization Products | 11/29/2007SE |
| K062297 | VHP 136 Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 10/04/2007SE |
| K042116 | Sterrad NX SterilizerMLR · Traditional | Advanced Sterilization Products | 04/22/2005SE |
| K030429 | Sterrad 200 SterilizerMLR · Traditional | Advanced Sterilization Products | 08/18/2003SE |
| K991999 | Sterrad 100S SterilizerMLR · Traditional | Advanced Sterilization Products | 06/15/2000SE |
| K981625 | Sterrad 50 SterilizerMLR · Traditional | Advanced Sterilization Products | 01/11/1999SE |
| K943654 | Harvey Chemiclave EC5000, EC5500, EC6000 SterilizersMLR · Traditional | Mdt Biologic Co. | 08/02/1995SE |
| K924380 | Mdt/Harvey Model 7000 & 8000 ChemiclaveMLR · Traditional | Mdt Corp., Inc. | 02/16/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2959-2018 Class II | AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The…There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered… | Steris Corporation | 07/26/2018Terminated |
| Z-0772-2018 Class II | V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a… | Steris Corporation | 09/28/2017Terminated |
| Z-1197-2017 Class II | STERRAD NX Sterilization System, Product Code: 10033, 10033-002Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external… | Advanced Sterilization Products | 01/09/2017Terminated |
| Z-2375-2015 Class II | Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed…Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it… | Advanced Sterilization Products | 07/17/2015Terminated |
| Z-0846-2015 Class II | STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD…Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on… | Advanced Sterilization Products | 11/04/2014Terminated |
| Z-0845-2015 Class II | STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization…Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on… | Advanced Sterilization Products | 11/04/2014Terminated |
| Z-0844-2015 Class II | STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization…Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on… | Advanced Sterilization Products | 11/04/2014Terminated |
| Z-0744-2014 Class II | STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System…Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S… | Advanced Sterilization Products | 12/16/2013Terminated |
| Z-0616-2014 Class II | SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS…Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of… | Steris Corporation | 11/21/2013Terminated |
| Z-0403-2014 Class II | STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature…Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems… | Advanced Sterilization Products | 11/11/2013Terminated |
| Z-0402-2014 Class II | STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low…Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems… | Advanced Sterilization Products | 11/11/2013Terminated |
| Z-0190-2014 Class II | Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive…Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers… | Advanced Sterilization Products | 10/18/2013Terminated |
| Z-0044-2014 Class II | STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general…Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX… | Advanced Sterilization Products | 09/18/2013Terminated |
| Z-0043-2014 Class II | STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double…Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit… | Advanced Sterilization Products | 09/18/2013Terminated |
| Z-2174-2013 Class II | STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low…The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does… | Advanced Sterilization Products | 07/25/2013Terminated |
| Z-1027-2013 Class II | STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization…The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX… | Advanced Sterilization Products | 03/22/2013Terminated |
| Z-1026-2013 Class II | STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX…The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX… | Advanced Sterilization Products | 03/22/2013Terminated |
| Z-0661-2013 Class II | STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are…Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not… | Advanced Sterilization Products | 09/20/2012Terminated |
| Z-2417-2012 Class II | Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone…STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications.… | Steris Corporation | 07/03/2012Terminated |
| Z-2338-2012 Class III | STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations…Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System… | Advanced Sterilization Products | 06/19/2012Terminated |
| Z-2337-2012 Class III | STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations…Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System… | Advanced Sterilization Products | 06/19/2012Terminated |
| Z-0998-2013 Class II | STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading…Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can… | Advanced Sterilization Products | 03/13/2012Terminated |
| Z-0741-2012 | STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer.…ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over… | Advanced Sterilization Products | 01/23/2012Terminated |
| Z-3124-2011 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001…STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system. | Steris Corporation | 08/11/2011Terminated |
| Z-3041-2011 | Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR…STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may… | Steris Corporation | 08/01/2011Terminated |
| Z-0823-2011 | Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS…Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm… | Steris Corporation | 07/02/2010Terminated |
| Z-1420-2009 | STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a…ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and… | Advanced Sterilization Products | 03/09/2009Terminated |
| Z-1570-2009 | Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer…The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially… | Advanced Sterilization Products | 01/12/2009Terminated |
| Z-0468-2012 | STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The…Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX… | Advanced Sterilization Products | 12/10/2008Terminated |
| Z-0340-2009 | STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and…1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being… | Advanced Sterilization Products | 10/17/2008Terminated |
| Z-0484-2009 | STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen…ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX… | Advanced Sterilization Products | 10/07/2008Terminated |
| Z-1632-2008 | STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | Advanced Sterilization Products | 02/25/2008Terminated |
| Z-1631-2008 | STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | Advanced Sterilization Products | 02/25/2008Terminated |
| Z-1630-2008 | STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | Advanced Sterilization Products | 02/25/2008Terminated |
| Z-1629-2008 | STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | Advanced Sterilization Products | 02/25/2008Terminated |
| Z-1628-2008 | STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | Advanced Sterilization Products | 02/25/2008Terminated |
| Z-0848-2008 | STERRAD NX Sterilizer, Product Code: 10033, Advanced Sterilization Products, Irvine, CAUser Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments… | Advanced Sterilization Products | 11/12/2007Terminated |
| Z-0847-2008 | STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CAUser Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments… | Advanced Sterilization Products | 11/12/2007Terminated |
| Z-0846-2008 | STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CAUser Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments… | Advanced Sterilization Products | 11/12/2007Terminated |
| Z-0845-2008 | STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CAUser Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments… | Advanced Sterilization Products | 11/12/2007Terminated |
| Z-0844-2008 | STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for…Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical… | Advanced Sterilization Products | 11/12/2007Terminated |