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

Vidacare Corporation — Predicate Candidate Screening

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

81 daysmedian FDA review time
177 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132583EZ-IO INTRAOSSEOUS INFUSION SYSTEMVidacare Corporation2014-02-111790
K120661THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACREVidacare Corporation2012-06-03901
K113872THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACAREVidacare Corporation2012-03-08691
K101026POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PVidacare Corporation2010-07-271050
K091140EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOVidacare Corporation2009-10-141771
K081713VERTEBRAL ACCESS SYSTEM BY VIDACAREVidacare Corporation2008-11-211570
K072045ONCONTROL BONE MARROW BIOPSY SYSTEMVidacare Corporation2007-10-22890
K070759POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEMVidacare Corporation2007-05-21620
K063567EZ-MIO STERNALVidacare Corporation2007-01-26590
K063142MANUAL PD-IO; POWERED PD-IOVidacare Corporation2006-12-08530
K062956EZ-MIO, EZ-IO DISTAL TIBIAVidacare Corporation2006-12-05670
K062833POWERED EZ-IO BONE MARROW ASPIRATION SYSTEMVidacare Corporation2006-11-30700
K062422HUMERAL HEAD, MANUAL DRIVERVidacare Corporation2006-11-07810
K061771EZ-CONNECTVidacare Corporation2006-07-10170
K052408EZ-IOVidacare Corporation2005-11-17771
K052195EZ-MIO MANUAL DRIVERVidacare Corporation2005-11-02830
K051992POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEMVidacare Corporation2005-10-20900
K043490PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLEVidacare Corporation2005-02-18630
K032885VIDAPORT INTRAOSSEOUS INFUSION SYSTEMVidacare Corporation2004-03-101760

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