Atlas FDA

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

Devon Medical, Inc. — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

36 daysmedian FDA review time
191 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump andDevon Medical, Inc.2014-09-191910
K132225EXTRICAREDevon Medical, Inc.2014-05-153020
K131464EXTRICARE NPWT FOOT DRESSINGDevon Medical, Inc.2013-08-13840
K131743CIRONA DVT FOOT GARMENTDevon Medical, Inc.2013-07-01180
K130571DEVON CIRONA 6100 DVTDevon Medical, Inc.2013-04-09360
K123959CIRCUFLOW 5150Devon Medical, Inc.2013-02-28690
K123647CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICEDevon Medical, Inc.2013-02-14790
K102582ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICEDevon Medical, Inc.2010-10-07290
K101523CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICEDevon Medical, Inc.2010-06-17150
K100446CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICEDevon Medical, Inc.2010-03-05160
K090664DEVON ACCUBP CUFFDevon Medical, Inc.2009-03-23100

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