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MED

64 FDA 510(k) clearances · Product code

175 daysmedian time to decision
637 days90th percentile
64clearances measured

FDA profile

Official device name
Sterilant, Medical Devices
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6885
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 74 · 2018: 42 · 2019: 35 · 2020: 32 · 2021: 31 · 2022: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K251666)STERIS Corporation2026-04-08
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) (K232914)STERIS Corporation2023-10-03
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K230582)STERIS Corporation2023-03-28
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 (K222615)STERIS Corporation2022-09-28
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 (K211607)STERIS Corporation2021-09-07
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 (K210737)STERIS Corporation2021-05-12
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 (K192929)STERIS Corporation2019-12-10
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (K191343)STERIS Corporation2019-09-05
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System (K190104)Steris Corporations2019-03-22
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (K182827)STERIS Corporation2019-01-31
SYSTEM 1E Liquid Chemical Sterilant Processing System (K180342)Steris Corporations2018-04-04
System 1 endo Liquid Chemical Sterilant Processing System (K173256)STERIS Corporation2018-03-02
SYSTEM 1E Liquid Chemical Sterilant Processing System (K170956)STERIS Corporation2017-09-22
SYSTEM 1E Liquid Chemical Sterilant Processing System (K161683)STERIS Corporation2016-08-05
OPA 30 SOLUTION (K140703)Ciden Technologies, LLC2014-08-19
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K131078)STERIS Corporation2013-07-05
RAPICIDE OPA-28 (K120306)Minntech Corp.2012-09-27
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K113520)STERIS Corporation2012-02-21
ALDAHOL V HIGH LEVEL DISINFECTANT (K113015)Microchem Laboratories, Inc.2012-01-30
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K102462)STERIS Corporation2010-09-21
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM (K101409)STERIS Corporation2010-08-02
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT (K091022)STERIS Corporation2010-04-12
SYSTEM 1.5 STERILE PROCESSING SYSTEM (K090036)STERIS Corporation2010-04-05
EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT (K091890)Healthpoint, Ltd.2010-03-24
ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT (K091210)Best Sanitizers, Inc.2010-02-05
RESERT XL HLD HIGH LEVEL DISINFECTANT (K080420)STERIS Corporation2008-09-02
OPACIDEN SOLUTION (K070627)Ciden Technologies, LLC2007-08-02
STERILOX LIQUID CHEMICAL STERILANT SYSTEM (K063159)Puricore, Inc.2007-04-02
POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 (K061356)Advanced Infusion, Inc.2006-07-03
CIDEX ACTIVATED DIALDEHYDE SOLUTION (K060618)Johnson & Johnson Co.2006-04-12
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT (K041984)Best Sanitizers, Inc.2005-05-11
ALDAHOL III HIGH-LEVEL DISINFECTANT (K041360)Healthpoint, Ltd.2005-05-05
CIDEX OPA CONCENTRATE (K032959)Advanced Sterilization Products2005-04-04
DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL (K033381)Discus Dental, Inc.2004-01-27
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT (K012889)Pascal Co., Inc.2003-05-27
0.55% ORTH-PHTHALALDEHYDE SOLUTION (K030004)Advanced Sterilization Products2003-02-27
STERILOX LIQUID CHEMICAL STERILANT SYSTEM (K013280)Sterilox Technologies, Inc.2002-09-18
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (K003087)Sporicidin Intl.2000-11-07
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) (K002401)Advanced Sterilization Products2000-08-29
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (K993042)Medivators, Inc.2000-08-17
CIDEX OPA SOLUTION (K001381)Advanced Sterilization Products2000-05-17
CIDEX OPA SOLUTION (K991487)Advanced Sterilization Products1999-10-08
ENDO-SPOR PLUS / HYPROCIDE (K972708)Cottrell, Ltd.1999-09-13
VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 (K984270)Roger L. Goodman, D.D.S., P.C.1999-05-20
SPOROX II STERILIZING & DISINFECTING SOLUTION (K990703)Reckitt Benckiser, Inc.1999-03-30
SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) (K983194)Sporicidin Intl.1999-03-05
CETYLCIDE-G (K974188)Kellerandheckman1998-09-10
MEDSCI 3% GLUTARALDEHYDE (K974062)Medsci, Inc.1998-09-02
PERACIDIN DIALYZER REPROCESSING CONCENTRATE (K962959)Hdc Medical, Inc.1998-06-05
VAPOCIDE (K970726)Cottrell, Ltd.1998-05-18
VAPOPHENE (K961289)Germiphene Corp.1997-12-04
SPOROX (K970230)Reckitt Benckiser, Inc.1997-10-29
PERACT 20 LIQUID STERILANT (K960513)Minntech Corp.1997-10-01
WAVICIDE(R) -01 (K914749)Wave Energy Systems, Inc.1995-08-10
PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR (K932922)Cottrell, Ltd.1995-07-03
METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE (K931592)Metrex Research Corp.1994-12-06
METRICIDE (K930284)Metrex Research Corp.1994-12-06
METRICIDE 28 (K931052)Metrex Research Corp.1994-12-06
WAVICIDE MONITOR STRIPS (K932047)Serim Research Corp.1994-06-02
CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE (K924334)Johnson & Johnson Medical, Inc.1994-03-29
HOMEPUMP NSF (K932740)Block Medical, Inc.1993-10-06
PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR (K915170)Pymah Corp.1992-07-28
SERIM DISINTEK REAGENT STRIPS (K913943)Serim Research Corp.1992-03-26
STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT (K875280)Steris C/O Medical Device Consultants, Inc.1988-09-13

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