Atlas FDA

FLF

26 FDA 510(k) clearances · Product code

260 daysmedian time to decision
652 days90th percentile
26clearances measured

FDA profile

Official device name
Sterilizer, Ethylene-Oxide Gas
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6860
Medical specialty
General Hospital
Adverse events (MAUDE)
1999: 1 · 2000: 2 · 2007: 2 · 2010: 3 · 2012: 5 · 2014: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EOGas 4 Ethylene Oxide Gas Sterilizer (K192978)Andersen Sterilizers, Inc.2020-11-12
Anprolene AN75 Ethylene Oxide Gas Sterilizer (K170432)Andersen Sterilizers, Inc.2017-10-31
EOGas 4 Ethylene Oxide Gas Sterilizer (K150646)Andersen Sterilizers, Inc.2015-11-18
3M STERI-VAC STERILIZER/AERATOR (K142034)3M Company2015-01-08
TSO3 OZONE STERILIZER, MODEL 125L (K090636)Tso3, Inc.2009-12-02
TSO3 OZONE STERILIZER, MODEL 125L (K051595)Tso3, Inc.2006-07-26
TSO3 OZONE STERILIZER, MODEL 125L (K020875)Technologies of Sterilization With Oxone, Tso3, Inc.2003-08-26
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (K014013)H & W Technology, LLC2003-06-25
STERRAD 50 & STERRAD 100S STERILIZERS (K023290)Advanced Sterilization Products2003-04-03
ABTOX PLAZLYTE PROCESS MONITOR (K923442)Abtox, Inc.1994-12-22
PLAZLYTE(TM) (K905119)Abtox, Inc.1994-12-22
STERI-VAC GAS STERILIZER MODEL 8XL (K941748)3M Health Care, Ltd.1994-12-02
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER (K931872)American Sterilizer Co.1994-02-07
STERRAD 100 STERILIZATION SYSTEM (K915682)Johnson & Johnson Medical, Inc.1993-10-01
MDT/CASTLE 10/90 DUAL LOAD STATION (K920930)Mdt Corp., Inc.1993-03-31
MDT/CASTLE 10/90 LOAD STATION (K910649)Mdt Biologic Co.1991-09-06
JOSLYN EO STERILIZER/ EO MODERNIZATION KIT (K901146)Joslyn Valve Corp.1991-03-07
STERI-VAC GAS STERILIZER MODEL 5XL (K902036)3M Company1990-07-19
KARLSON OZONE STERILIZER MODEL 100B (K873200)Life Enhancement Technologies, LLC1989-01-27
ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER (K852115)Ars Enterprises, Inc.1985-11-01
ETHYLENE OXIDE GAS STERILIZA SYS II (K833457)Ben Venue Laboratories, Inc.1983-12-29
EAGLE 2000 STERILIZER SERIES GAS/AERA (K832945)Amsco Co.1983-10-19
GAS STERILIZATION EQUIPMENT (K821842)Getinge International, Inc.1982-07-28
CASTLE MICROCOMPUTER STERILIZER CONTROL (K820783)Sybron Corp.1982-04-15
STERI-VAC #400C GAS STERILIZER (K812867)3M Company1981-11-02
1500 EO EXHAUST HOOD (K792660)Castle Co.1980-01-29

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Every clearance here is in the API, with alerts when new ones post.