Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

ECX — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

209 daysmedian FDA review time
305 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161179Intelli-OxAir Liquide Healthcare America Corporation2017-04-133520
K161472Walk-O2-BoutEssex Industries, Inc.2016-11-181750
K153518Medipure Oxygen-LC SystemPraxair Distribution, Incorporated.2016-06-031780
K143060Intelli-OxAir Liquide Healthcare2015-05-212090
K142149OXYTOTE INFINITY SERIES VIPR SYSTEMSWestern/Scott Fetzer Co.2015-04-172550
K132778GRAB 'N GO PLUS, GRAB 'N GO DIGITALPraxair Healthcare Services2014-07-073050
K131386EZ-OX PLUS GENERATION IIAir Liquide Healthcare America2014-03-143040
K101792LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M7Linde Gas North America, LLC2011-03-182630
K063354LINDE INTEGRATED VALVE (LIV)Linde Gas Therapeutics2007-04-171620
K062300OX-SOX, MODEL C, D, E,Pattient Safety Innovations, Llp2006-11-271110
K053117EZ-OX PLUSAir Liquide Healthcare America2006-04-101540
K033897MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEMAga-Linde Health Care2004-07-192160
K771246ALARM SYS FOR NITROUS OXIDE SYS.Star Dental Mfg. Co.1977-07-1540

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda