FDA 510(k) Applications for Medical Device Product Code "MLR"
(Sterilizer, Chemical)

FDA 510(k) Number Applicant Device Name Decision Date
K071385 ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER 11/29/2007
K092622 ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER EXPRESS CYCLE 03/04/2011
K160903 ADVANCED STERILIZATION PRODUCTS STERRAD 100NX Sterilizer with ALLClearTM Technology 09/26/2016
K991999 ADVANCED STERILIZATION PRODUCTS STERRAD 100S STERILIZER 06/15/2000
K030429 ADVANCED STERILIZATION PRODUCTS STERRAD 200 STERILIZER 08/18/2003
K981625 ADVANCED STERILIZATION PRODUCTS STERRAD 50 STERILIZER 01/11/1999
K042116 ADVANCED STERILIZATION PRODUCTS STERRAD NX STERILIZER 04/22/2005
K162007 Advanced Sterilization Products STERRAD NX Sterilizer 02/16/2017
K142454 ADVANCED STERILIZATION PRODUCTS STERRAD NX Sterilizer, STERRAD 100NX Sterilizer 04/03/2015
K151725 ADVANCED STERILIZATION PRODUCTS STERRAD NX Sterilizer, STERRAD 100NX Sterilizer 01/13/2016
K160818 ADVANCED STERILIZATION PRODUCTS STERRAD« NX Sterilizer with ALLClearÖ Technology 09/27/2016
K111377 ADVANCED STERILIZATION PRODUCTS STERRAD(R) 100NX STERILIZER DUO CYCLE 09/13/2012
K212174 Advanced Sterilization Products, Inc. STERRAD 100NX Sterilizer with ALLClear Technology 10/09/2021
K220404 Advanced Sterilization Products, Inc. STERRAD NX with ALLClear Technology 05/16/2022
K212200 Plasmapp Co,.Ltd STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette 10/22/2021
K220345 Plasmapp Co., Ltd. STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terrage 04/14/2023
K231169 Plasmapp Co., Ltd. STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) 05/25/2023
K223015 Plasmapp Co., Ltd. STERLINKÖ FPS-15s Plus sterilizer with STERPACKÖ plus cassette 05/09/2023
K140464 STERILUCENT, INC STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER 10/31/2014
K190005 Sterilucent, Inc. Sterilucent HC 80TT Hydrogen Peroxide Sterilizer 09/13/2019
K222093 STERIS V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System 09/09/2022
K112813 STERIS CORP. AMSCO V-PRO 12/01/2011
K111810 STERIS Corporation AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS 09/02/2011
K083097 STERIS Corporation AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM 08/03/2009
K162413 STERIS Corporation AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System 03/31/2017
K172319 STERIS Corporation AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System 01/18/2018
K102394 STERIS Corporation AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM 08/18/2011
K131120 STERIS Corporation AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM 07/16/2013
K120632 STERIS Corporation AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM 06/26/2012
K102330 STERIS Corporation AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM 08/12/2011
K112760 STERIS Corporation AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM 11/22/2011
K190917 STERIS Corporation V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems 05/09/2019
K140498 STERIS Corporation V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM 07/24/2014
K223476 Steris Corporation V-PRO maX 2 Low Temperature Sterilization System 08/07/2023
K172754 Steris Corporation V-PRO maX 2 Low Temperature Sterilization System 02/09/2018
K190103 STERIS Corporation V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System 04/05/2019
K182568 STERIS Corporation V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System 01/03/2019
K160433 STERIS CORPORATION V-PRO« 1 Plus and V-PRO« maX Low Temperature 07/06/2016
K062297 STERIS Corporation VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM 10/04/2007


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