Atlas FDA

ECX

13 FDA 510(k) clearances · Product code

209 daysmedian time to decision
305 days90th percentile
13clearances measured

FDA profile

Official device name
Cylinder, Compressed Gas, And Valve
Device class
Class I (low risk)
Regulation
21 CFR 868.2700
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2007: 4 · 2008: 6 · 2009: 3 · 2010: 7 · 2011: 7 · 2014: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Intelli-Ox (K161179)Air Liquide Healthcare America Corporation2017-04-13
Walk-O2-Bout (K161472)Essex Industries, Inc.2016-11-18
Medipure Oxygen-LC System (K153518)Praxair Distribution, Incorporated.2016-06-03
Intelli-Ox (K143060)Air Liquide Healthcare2015-05-21
OXYTOTE INFINITY SERIES VIPR SYSTEMS (K142149)Western/Scott Fetzer Co.2015-04-17
GRAB 'N GO PLUS, GRAB 'N GO DIGITAL (K132778)Praxair Healthcare Services2014-07-07
EZ-OX PLUS GENERATION II (K131386)Air Liquide Healthcare America2014-03-14
LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 (K101792)Linde Gas North America, LLC2011-03-18
LINDE INTEGRATED VALVE (LIV) (K063354)Linde Gas Therapeutics2007-04-17
OX-SOX, MODEL C, D, E, (K062300)Pattient Safety Innovations, Llp2006-11-27
EZ-OX PLUS (K053117)Air Liquide Healthcare America2006-04-10
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM (K033897)Aga-Linde Health Care2004-07-19
ALARM SYS FOR NITROUS OXIDE SYS. (K771246)Star Dental Mfg. Co.1977-07-15

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