Product Code: FLF FDA class 2 21 CFR 880.6860

Sterilizer, Ethylene-Oxide Gas

General Hospital

The Ethylene-Oxide Gas Sterilizer is a device used in healthcare settings to sterilize heat-sensitive medical instruments and materials using ethylene oxide gas, which kills microorganisms including spores. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLF, regulated under 21 CFR 880.6860 in the General Hospital specialty.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: FLF
Device Class: FDA class 2
Regulation Number: 880.6860
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192978	EOGas 4 Ethylene Oxide Gas Sterilizer	Nov 12, 2020	Substantially Equivalent	Andersen Sterilizers, Inc.
K170432	Anprolene AN75 Ethylene Oxide Gas Sterilizer	Oct 31, 2017	Substantially Equivalent	Andersen Sterilizers, Inc.
K150646	EOGas 4 Ethylene Oxide Gas Sterilizer	Nov 18, 2015	Substantially Equivalent	Andersen Sterilizers, Inc.
K142034	3M STERI-VAC STERILIZER/AERATOR	Jan 08, 2015	Substantially Equivalent	3M Company
K090636	TSO3 OZONE STERILIZER, MODEL 125L	Dec 02, 2009	Substantially Equivalent	Tso3, Inc.
K051595	TSO3 OZONE STERILIZER, MODEL 125L	Jul 26, 2006	Substantially Equivalent	Tso3, Inc.
K020875	TSO3 OZONE STERILIZER, MODEL 125L	Aug 26, 2003	Substantially Equivalent	Technologies of Sterilization With Oxone, Tso3, Inc.
K014013	H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM	Jun 25, 2003	Substantially Equivalent	H & W Technology, LLC
K023290	STERRAD 50 & STERRAD 100S STERILIZERS	Apr 03, 2003	Substantially Equivalent	Advanced Sterilization Products
K923442	ABTOX PLAZLYTE PROCESS MONITOR	Dec 22, 1994	Substantially Equivalent	Abtox, Inc.
K905119	PLAZLYTE(TM)	Dec 22, 1994	Substantially Equivalent	Abtox, Inc.
K941748	STERI-VAC GAS STERILIZER MODEL 8XL	Dec 02, 1994	Substantially Equivalent	3M Health Care, Ltd.
K931872	THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER	Feb 07, 1994	Substantially Equivalent	American Sterilizer Co.
K915682	STERRAD 100 STERILIZATION SYSTEM	Oct 01, 1993	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K920930	MDT/CASTLE 10/90 DUAL LOAD STATION	Mar 31, 1993	Substantially Equivalent	Mdt Corp., Inc.
K910649	MDT/CASTLE 10/90 LOAD STATION	Sep 06, 1991	Substantially Equivalent	Mdt Biologic Co.
K901146	JOSLYN EO STERILIZER/ EO MODERNIZATION KIT	Mar 07, 1991	Substantially Equivalent	Joslyn Valve Corp.
K902036	STERI-VAC GAS STERILIZER MODEL 5XL	Jul 19, 1990	Substantially Equivalent	3M Company
K873200	KARLSON OZONE STERILIZER MODEL 100B	Jan 27, 1989	Substantially Equivalent	Life Enhancement Technologies, LLC
K852115	ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER	Nov 01, 1985	Substantially Equivalent	Ars Enterprises, Inc.
K833457	ETHYLENE OXIDE GAS STERILIZA SYS II	Dec 29, 1983	Substantially Equivalent	Ben Venue Laboratories, Inc.
K832945	EAGLE 2000 STERILIZER SERIES GAS/AERA	Oct 19, 1983	Substantially Equivalent	Amsco Co.
K821842	GAS STERILIZATION EQUIPMENT	Jul 28, 1982	Substantially Equivalent	Getinge International, Inc.
K820783	CASTLE MICROCOMPUTER STERILIZER CONTROL	Apr 15, 1982	Substantially Equivalent	Sybron Corp.
K812867	STERI-VAC #400C GAS STERILIZER	Nov 02, 1981	Substantially Equivalent	3M Company
K792660	1500 EO EXHAUST HOOD	Jan 29, 1980	Substantially Equivalent	Castle Co.