FDA 510(k) Applications for Medical Device Product Code "MED"
(Sterilant, Medical Devices)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K061356 | ADVANCED INFUSION, INC. | POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 | 07/03/2006 |
| K030004 | ADVANCED STERILIZATION PRODUCTS | 0.55% ORTH-PHTHALALDEHYDE SOLUTION | 02/27/2003 |
| K032959 | ADVANCED STERILIZATION PRODUCTS | CIDEX OPA CONCENTRATE | 04/04/2005 |
| K001381 | ADVANCED STERILIZATION PRODUCTS | CIDEX OPA SOLUTION | 05/17/2000 |
| K991487 | ADVANCED STERILIZATION PRODUCTS | CIDEX OPA SOLUTION | 10/08/1999 |
| K002401 | ADVANCED STERILIZATION PRODUCTS | CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) | 08/29/2000 |
| K041984 | BEST SANITIZERS, INC. | ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT | 05/11/2005 |
| K091210 | BEST SANITIZERS, INC. | ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT | 02/05/2010 |
| K140703 | CIDEN TECHNOLOGIES LLC | OPA 30 SOLUTION | 08/19/2014 |
| K070627 | CIDEN TECHNOLOGIES LLC | OPACIDEN SOLUTION | 08/02/2007 |
| K972708 | COTTRELL, LTD. | ENDO-SPOR PLUS / HYPROCIDE | 09/13/1999 |
| K970726 | COTTRELL, LTD. | VAPOCIDE | 05/18/1998 |
| K033381 | DISCUS DENTAL INC. | DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL | 01/27/2004 |
| K961289 | GERMIPHENE CORP. | VAPOPHENE | 12/04/1997 |
| K962959 | HDC MEDICAL, INC. | PERACIDIN DIALYZER REPROCESSING CONCENTRATE | 06/05/1998 |
| K041360 | HEALTHPOINT, LTD. | ALDAHOL III HIGH-LEVEL DISINFECTANT | 05/05/2005 |
| K091890 | HEALTHPOINT, LTD. | EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT | 03/24/2010 |
| K060618 | JOHNSON & JOHNSON CO. | CIDEX ACTIVATED DIALDEHYDE SOLUTION | 04/12/2006 |
| K974188 | KELLER AND HECKMAN | CETYLCIDE-G | 09/10/1998 |
| K993042 | MEDIVATORS, INC. | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT | 08/17/2000 |
| K974062 | MEDSCI, INC. | MEDSCI 3% GLUTARALDEHYDE | 09/02/1998 |
| K113015 | MICROCHEM LABORATORIES, INC. | ALDAHOL V HIGH LEVEL DISINFECTANT | 01/30/2012 |
| K960513 | MINNTECH CORP. | PERACT 20 LIQUID STERILANT | 10/01/1997 |
| K120306 | MINNTECH CORP. | RAPICIDE OPA-28 | 09/27/2012 |
| K012889 | PASCAL CO., INC. | BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT | 05/27/2003 |
| K063159 | PURICORE, INC. | STERILOX LIQUID CHEMICAL STERILANT SYSTEM | 04/02/2007 |
| K970230 | RECKITT BENCKISER, INC. | SPOROX | 10/29/1997 |
| K990703 | RECKITT BENCKISER, INC. | SPOROX II STERILIZING & DISINFECTING SOLUTION | 03/30/1999 |
| K984270 | ROGER L. GOODMAN, D.D.S., P.C. | VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 | 05/20/1999 |
| K003087 | SPORICIDIN INTL. | MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION | 11/07/2000 |
| K983194 | SPORICIDIN INTL. | SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) | 03/05/1999 |
| K013280 | STERILOX TECHNOLOGIES, INC. | STERILOX LIQUID CHEMICAL STERILANT SYSTEM | 09/18/2002 |
| K091022 | STERIS Corporation | MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT | 04/12/2010 |
| K080420 | STERIS Corporation | RESERT XL HLD HIGH LEVEL DISINFECTANT | 09/02/2008 |
| K173256 | Steris Corporation | System 1 endo Liquid Chemical Sterilant Processing System | 03/02/2018 |
| K182827 | STERIS Corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | 01/31/2019 |
| K230582 | STERIS Corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | 03/28/2023 |
| K191343 | STERIS Corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | 09/05/2019 |
| K090036 | STERIS Corporation | SYSTEM 1.5 STERILE PROCESSING SYSTEM | 04/05/2010 |
| K131078 | STERIS Corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | 07/05/2013 |
| K161683 | STERIS CORPORATION | SYSTEM 1E Liquid Chemical Sterilant Processing System | 08/05/2016 |
| K170956 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System | 09/22/2017 |
| K102462 | STERIS Corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | 09/21/2010 |
| K113520 | STERIS Corporation | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | 02/21/2012 |
| K232914 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | 10/03/2023 |
| K192929 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | 12/10/2019 |
| K210737 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | 05/12/2021 |
| K211607 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | 09/07/2021 |
| K222615 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | 09/28/2022 |
| K101409 | STERIS Corporation | SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM | 08/02/2010 |
| K180342 | Steris Corporations | SYSTEM 1E Liquid Chemical Sterilant Processing System | 04/04/2018 |
| K190104 | Steris Corporations | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | 03/22/2019 |
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