Product Code: MED FDA class 2 21 CFR 880.6885

Sterilant, Medical Devices

General Hospital

The medical device sterilant is a general hospital chemical agent or system used to achieve sterilization of heat-sensitive reusable medical instruments and equipment, destroying all forms of microbial life including bacterial spores. It is classified as FDA Class II under 21 CFR 880.6885 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MED and the device is not implanted. Full GMP quality system requirements apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MED
Device Class: FDA class 2
Regulation Number: 880.6885
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251666	SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900	Apr 08, 2026	Substantially Equivalent	STERIS Corporation
K232914	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)	Oct 03, 2023	Substantially Equivalent	STERIS Corporation
K230582	SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900	Mar 28, 2023	Substantially Equivalent	STERIS Corporation
K222615	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	Sep 28, 2022	Substantially Equivalent	STERIS Corporation
K211607	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	Sep 07, 2021	Substantially Equivalent	STERIS Corporation
K210737	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	May 12, 2021	Substantially Equivalent	STERIS Corporation
K192929	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	Dec 10, 2019	Substantially Equivalent	STERIS Corporation
K191343	SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900	Sep 05, 2019	Substantially Equivalent	STERIS Corporation
K190104	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System	Mar 22, 2019	Substantially Equivalent	Steris Corporations
K182827	SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900	Jan 31, 2019	Substantially Equivalent	STERIS Corporation
K180342	SYSTEM 1E Liquid Chemical Sterilant Processing System	Apr 04, 2018	Substantially Equivalent	Steris Corporations
K173256	System 1 endo Liquid Chemical Sterilant Processing System	Mar 02, 2018	Substantially Equivalent	STERIS Corporation
K170956	SYSTEM 1E Liquid Chemical Sterilant Processing System	Sep 22, 2017	Substantially Equivalent	STERIS Corporation
K161683	SYSTEM 1E Liquid Chemical Sterilant Processing System	Aug 05, 2016	Substantially Equivalent	STERIS Corporation
K140703	OPA 30 SOLUTION	Aug 19, 2014	Substantially Equivalent	Ciden Technologies, LLC
K131078	SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM	Jul 05, 2013	Substantially Equivalent	STERIS Corporation
K120306	RAPICIDE OPA-28	Sep 27, 2012	Substantially Equivalent	Minntech Corp.
K113520	SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM	Feb 21, 2012	Substantially Equivalent	STERIS Corporation
K113015	ALDAHOL V HIGH LEVEL DISINFECTANT	Jan 30, 2012	Substantially Equivalent	Microchem Laboratories, Inc.
K102462	SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM	Sep 21, 2010	Substantially Equivalent	STERIS Corporation
K101409	SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM	Aug 02, 2010	Substantially Equivalent	STERIS Corporation
K091022	MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT	Apr 12, 2010	Substantially Equivalent	STERIS Corporation
K090036	SYSTEM 1.5 STERILE PROCESSING SYSTEM	Apr 05, 2010	Substantially Equivalent	STERIS Corporation
K091890	EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT	Mar 24, 2010	Substantially Equivalent	Healthpoint, Ltd.
K091210	ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT	Feb 05, 2010	Substantially Equivalent	Best Sanitizers, Inc.
K080420	RESERT XL HLD HIGH LEVEL DISINFECTANT	Sep 02, 2008	Substantially Equivalent	STERIS Corporation
K070627	OPACIDEN SOLUTION	Aug 02, 2007	Substantially Equivalent	Ciden Technologies, LLC
K063159	STERILOX LIQUID CHEMICAL STERILANT SYSTEM	Apr 02, 2007	Substantially Equivalent	Puricore, Inc.
K061356	POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6	Jul 03, 2006	Substantially Equivalent	Advanced Infusion, Inc.
K060618	CIDEX ACTIVATED DIALDEHYDE SOLUTION	Apr 12, 2006	Substantially Equivalent	Johnson & Johnson Co.
K041984	ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT	May 11, 2005	Substantially Equivalent	Best Sanitizers, Inc.
K041360	ALDAHOL III HIGH-LEVEL DISINFECTANT	May 05, 2005	Substantially Equivalent	Healthpoint, Ltd.
K032959	CIDEX OPA CONCENTRATE	Apr 04, 2005	Substantially Equivalent	Advanced Sterilization Products
K033381	DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL	Jan 27, 2004	Substantially Equivalent	Discus Dental, Inc.
K012889	BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT	May 27, 2003	Substantially Equivalent	Pascal Co., Inc.
K030004	0.55% ORTH-PHTHALALDEHYDE SOLUTION	Feb 27, 2003	Substantially Equivalent	Advanced Sterilization Products
K013280	STERILOX LIQUID CHEMICAL STERILANT SYSTEM	Sep 18, 2002	Substantially Equivalent	Sterilox Technologies, Inc.
K003087	MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION	Nov 07, 2000	Substantially Equivalent	Sporicidin Intl.
K002401	CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)	Aug 29, 2000	Substantially Equivalent	Advanced Sterilization Products
K993042	MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT	Aug 17, 2000	Substantially Equivalent	Medivators, Inc.
K001381	CIDEX OPA SOLUTION	May 17, 2000	Substantially Equivalent	Advanced Sterilization Products
K991487	CIDEX OPA SOLUTION	Oct 08, 1999	Substantially Equivalent	Advanced Sterilization Products
K972708	ENDO-SPOR PLUS / HYPROCIDE	Sep 13, 1999	Substantially Equivalent	Cottrell, Ltd.
K984270	VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000	May 20, 1999	Substantially Equivalent	Roger L. Goodman, D.D.S., P.C.
K990703	SPOROX II STERILIZING & DISINFECTING SOLUTION	Mar 30, 1999	Substantially Equivalent	Reckitt Benckiser, Inc.
K983194	SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)	Mar 05, 1999	Substantially Equivalent	Sporicidin Intl.
K974188	CETYLCIDE-G	Sep 10, 1998	Substantially Equivalent	Kellerandheckman
K974062	MEDSCI 3% GLUTARALDEHYDE	Sep 02, 1998	Substantially Equivalent	Medsci, Inc.
K962959	PERACIDIN DIALYZER REPROCESSING CONCENTRATE	Jun 05, 1998	Substantially Equivalent	Hdc Medical, Inc.
K970726	VAPOCIDE	May 18, 1998	Substantially Equivalent	Cottrell, Ltd.
K961289	VAPOPHENE	Dec 04, 1997	Substantially Equivalent	Germiphene Corp.
K970230	SPOROX	Oct 29, 1997	Substantially Equivalent	Reckitt Benckiser, Inc.
K960513	PERACT 20 LIQUID STERILANT	Oct 01, 1997	Substantially Equivalent	Minntech Corp.
K914749	WAVICIDE(R) -01	Aug 10, 1995	Substantially Equivalent	Wave Energy Systems, Inc.
K932922	PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR	Jul 03, 1995	Substantially Equivalent	Cottrell, Ltd.
K931592	METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE	Dec 06, 1994	Substantially Equivalent	Metrex Research Corp.
K931052	METRICIDE 28	Dec 06, 1994	Substantially Equivalent	Metrex Research Corp.
K930284	METRICIDE	Dec 06, 1994	Substantially Equivalent	Metrex Research Corp.
K932047	WAVICIDE MONITOR STRIPS	Jun 02, 1994	Substantially Equivalent	Serim Research Corp.
K924334	CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE	Mar 29, 1994	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K932740	HOMEPUMP NSF	Oct 06, 1993	Substantially Equivalent	Block Medical, Inc.
K915170	PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR	Jul 28, 1992	Substantially Equivalent	Pymah Corp.
K913943	SERIM DISINTEK REAGENT STRIPS	Mar 26, 1992	Substantially Equivalent	Serim Research Corp.
K875280	STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT	Sep 13, 1988	Substantially Equivalent	Steris C/O Medical Device Consultants, Inc.