Sterilant, Medical Devices

FDA product code MED · 63 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.6885
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1988-09-13 – 2026-04-08

MED 2026-04-08

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Applicant STERIS Corporation

K number K251666

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MED 2023-10-03

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)

Applicant STERIS Corporation

K number K232914

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MED 2023-03-28

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Applicant STERIS Corporation

K number K230582

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MED 2022-09-28

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

Applicant STERIS Corporation

K number K222615

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MED 2021-09-07

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

Applicant STERIS Corporation

K number K211607

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MED 2021-05-12

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, S40 Sterilant Concentrate

Applicant STERIS Corporation

K number K210737

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MED 2019-12-10

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

Applicant STERIS Corporation

K number K192929

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MED 2019-09-05

SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900

Applicant STERIS Corporation

K number K191343

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MED 2019-03-22

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System

Applicant Steris Corporations

K number K190104

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MED 2019-01-31

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900

Applicant STERIS Corporation

K number K182827

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MED 2018-04-04

SYSTEM 1E Liquid Chemical Sterilant Processing System

Applicant Steris Corporations

K number K180342

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MED 2018-03-02

System 1 endo Liquid Chemical Sterilant Processing System

Applicant STERIS Corporation

K number K173256

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MED 2017-09-22

SYSTEM 1E Liquid Chemical Sterilant Processing System

Applicant STERIS Corporation

K number K170956

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MED 2016-08-05

SYSTEM 1E Liquid Chemical Sterilant Processing System

Applicant STERIS Corporation

K number K161683

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MED 2013-07-05

SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

Applicant STERIS Corporation

K number K131078

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MED 2012-09-27

RAPICIDE OPA-28

Applicant Minntech Corp.

K number K120306

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MED 2012-02-21

SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

Applicant STERIS Corporation

K number K113520

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MED 2012-01-30

ALDAHOL V HIGH LEVEL DISINFECTANT

Applicant Microchem Laboratories, Inc.

K number K113015

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MED 2010-09-21

SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

Applicant STERIS Corporation

K number K102462

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MED 2010-08-02

SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM

Applicant STERIS Corporation

K number K101409

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MED 2010-04-12

MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT

Applicant STERIS Corporation

K number K091022

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MED 2010-04-05

SYSTEM 1.5 STERILE PROCESSING SYSTEM

Applicant STERIS Corporation

K number K090036

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MED 2010-03-24

EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT

Applicant Healthpoint, Ltd.

K number K091890

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MED 2010-02-05

ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT

Applicant Best Sanitizers, Inc.

K number K091210

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MED 2008-09-02

RESERT XL HLD HIGH LEVEL DISINFECTANT

Applicant STERIS Corporation

K number K080420

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MED 2007-08-02

OPACIDEN SOLUTION

Applicant Ciden Technologies, LLC

K number K070627

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MED 2007-04-02

STERILOX LIQUID CHEMICAL STERILANT SYSTEM

Applicant Puricore, Inc.

K number K063159

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MED 2006-07-03

POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6

Applicant Advanced Infusion, Inc.

K number K061356

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MED 2006-04-12

CIDEX ACTIVATED DIALDEHYDE SOLUTION

Applicant Johnson & Johnson Co.

K number K060618

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MED 2005-05-11

ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT

Applicant Best Sanitizers, Inc.

K number K041984

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MED 2005-05-05

ALDAHOL III HIGH-LEVEL DISINFECTANT

Applicant Healthpoint, Ltd.

K number K041360

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MED 2005-04-04

CIDEX OPA CONCENTRATE

Applicant Advanced Sterilization Products

K number K032959

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MED 2004-01-27

DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL

Applicant Discus Dental, Inc.

K number K033381

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MED 2003-05-27

BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT

Applicant Pascal Co., Inc.

K number K012889

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MED 2003-02-27

0.55% ORTH-PHTHALALDEHYDE SOLUTION

Applicant Advanced Sterilization Products

K number K030004

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MED 2002-09-18

STERILOX LIQUID CHEMICAL STERILANT SYSTEM

Applicant Sterilox Technologies, Inc.

K number K013280

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MED 2000-11-07

MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION

Applicant Sporicidin Intl.

K number K003087

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MED 2000-08-29

CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)

Applicant Advanced Sterilization Products

K number K002401

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MED 2000-08-17

MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT

Applicant Medivators, Inc.

K number K993042

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MED 2000-05-17

CIDEX OPA SOLUTION

Applicant Advanced Sterilization Products

K number K001381

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MED 1999-10-08

CIDEX OPA SOLUTION

Applicant Advanced Sterilization Products

K number K991487

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MED 1999-09-13

ENDO-SPOR PLUS / HYPROCIDE

Applicant Cottrell, Ltd.

K number K972708

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MED 1999-05-20

VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000

Applicant Roger L. Goodman, D.D.S., P.C.

K number K984270

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MED 1999-03-30

SPOROX II STERILIZING & DISINFECTING SOLUTION

Applicant Reckitt Benckiser, Inc.

K number K990703

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MED 1999-03-05

SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)

Applicant Sporicidin Intl.

K number K983194

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MED 1998-09-10

CETYLCIDE-G

Applicant Kellerandheckman

K number K974188

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MED 1998-09-02

MEDSCI 3% GLUTARALDEHYDE

Applicant Medsci, Inc.

K number K974062

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MED 1998-06-05

PERACIDIN DIALYZER REPROCESSING CONCENTRATE

Applicant Hdc Medical, Inc.

K number K962959

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MED 1998-05-18

VAPOCIDE

Applicant Cottrell, Ltd.

K number K970726

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MED 1997-12-04

VAPOPHENE

Applicant Germiphene Corp.

K number K961289

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MED 1997-10-29

SPOROX

Applicant Reckitt Benckiser, Inc.

K number K970230

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MED 1997-10-01

PERACT 20 LIQUID STERILANT

Applicant Minntech Corp.

K number K960513

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MED 1995-08-10

WAVICIDE(R) -01

Applicant Wave Energy Systems, Inc.

K number K914749

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MED 1995-07-03

PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR

Applicant Cottrell, Ltd.

K number K932922

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MED 1994-12-06

METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE

Applicant Metrex Research Corp.

K number K931592

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MED 1994-12-06

METRICIDE 28

Applicant Metrex Research Corp.

K number K931052

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MED 1994-12-06

METRICIDE

Applicant Metrex Research Corp.

K number K930284

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MED 1994-06-02

WAVICIDE MONITOR STRIPS

Applicant Serim Research Corp.

K number K932047

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MED 1994-03-29

CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE

Applicant Johnson & Johnson Medical, Inc.

K number K924334

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MED 1993-10-06

HOMEPUMP NSF

Applicant Block Medical, Inc.

K number K932740

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MED 1992-07-28

PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR

Applicant Pymah Corp.

K number K915170

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MED 1992-03-26

SERIM DISINTEK REAGENT STRIPS

Applicant Serim Research Corp.

K number K913943

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MED 1988-09-13

STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT

Applicant Steris C/O Medical Device Consultants, Inc.

K number K875280

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