Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6860](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6860) → FLF — Sterilizer, Ethylene-Oxide Gas # FLF · Sterilizer, Ethylene-Oxide Gas _General Hospital · 21 CFR 880.6860 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF ## Overview - **Product Code:** FLF - **Device Name:** Sterilizer, Ethylene-Oxide Gas - **Regulation:** [21 CFR 880.6860](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6860) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 26) Showing 20 most recent of 26 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K192978](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K192978.md) | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | Nov 12, 2020 | SESE | | [K170432](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K170432.md) | Anprolene AN75 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | Oct 31, 2017 | SESE | | [K150646](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K150646.md) | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | Nov 18, 2015 | SESE | | [K142034](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K142034.md) | 3M STERI-VAC STERILIZER/AERATOR | 3M Company | Jan 8, 2015 | SESE | | [K090636](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K090636.md) | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | Dec 2, 2009 | SESE | | [K051595](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K051595.md) | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | Jul 26, 2006 | SESE | | [K020875](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K020875.md) | TSO3 OZONE STERILIZER, MODEL 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | Aug 26, 2003 | SESE | | [K014013](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K014013.md) | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM | H & W Technology, LLC | Jun 25, 2003 | SESE | | [K023290](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K023290.md) | STERRAD 50 & STERRAD 100S STERILIZERS | Advanced Sterilization Products | Apr 3, 2003 | SESE | | [K923442](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K923442.md) | ABTOX PLAZLYTE PROCESS MONITOR | Abtox, Inc. | Dec 22, 1994 | SESE | | [K905119](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K905119.md) | PLAZLYTE(TM) | Abtox, Inc. | Dec 22, 1994 | SESE | | [K941748](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K941748.md) | STERI-VAC GAS STERILIZER MODEL 8XL | 3M Health Care, Ltd. | Dec 2, 1994 | SESE | | [K931872](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K931872.md) | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | American Sterilizer Co. | Feb 7, 1994 | SESE | | [K915682](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K915682.md) | STERRAD 100 STERILIZATION SYSTEM | Johnson & Johnson Medical, Inc. | Oct 1, 1993 | SESE | | [K920930](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K920930.md) | MDT/CASTLE 10/90 DUAL LOAD STATION | Mdt Corp., Inc. | Mar 31, 1993 | SESE | | [K910649](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K910649.md) | MDT/CASTLE 10/90 LOAD STATION | Mdt Biologic Co. | Sep 6, 1991 | SESE | | [K901146](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K901146.md) | JOSLYN EO STERILIZER/ EO MODERNIZATION KIT | Joslyn Valve Corp. | Mar 7, 1991 | SESE | | [K902036](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K902036.md) | STERI-VAC GAS STERILIZER MODEL 5XL | 3M Company | Jul 19, 1990 | SESE | | [K873200](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K873200.md) | KARLSON OZONE STERILIZER MODEL 100B | Life Enhancement Technologies, LLC | Jan 27, 1989 | SESE | | [K852115](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K852115.md) | ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER | Ars Enterprises, Inc. | Nov 1, 1985 | SESE | ## Top Applicants - 3M Company — 3 clearances - Andersen Sterilizers, Inc. — 3 clearances - Abtox, Inc. — 2 clearances - Tso3, Inc. — 2 clearances - 3M Health Care, Ltd. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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