Atlas FDA

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

Advanced Vascular Dynamics — Predicate Candidate Screening

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

97 daysmedian FDA review time
246 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151363Zephyr Vascular Compression DeviceAdvanced Vascular Dynamics2015-07-31710
K142122RADAR VASCULAR COMPRESSION DEVICEAdvanced Vascular Dynamics2014-12-041220
K131571AVD RIGHT RADIAL DRAPEAdvanced Vascular Dynamics2014-01-312460
K093192FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICEAdvanced Vascular Dynamics2010-02-121260
K092503RADAR VASCULAR COMPRESSION DEVICESAdvanced Vascular Dynamics2009-11-19970
K090286PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICEAdvanced Vascular Dynamics2009-03-23460
K072167COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICEAdvanced Vascular Dynamics2007-09-06310
K040615COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTAdvanced Vascular Dynamics2004-06-01840

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