Atlas FDA

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

QBP — Predicate Candidate Screening

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

234 daysmedian FDA review time
332 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252006OTTO™ Disinfecting CapIcu Medical, Inc.2026-03-272730
K251592SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical2026-02-112640
K223914ACTIV™ CapCleansite Medical, Inc.2024-04-054630
K193190BD PureHub Disinfecting CapBecton, Dickinson and Company2020-11-093560
K200299Curos Jet Disinfecting Cap3M Company2020-10-292660
K192382CapKlenZStar Mountain Medical, Inc.2020-04-202340
K190918SwabTip Male Disinfectant CapIcu Medical2020-03-063320
K142806DualCapCatheter Connections, Inc.2015-05-222350
K140657CUROS RED PORT PROTECTORIvera Medical, Inc.2014-12-042650
K142399DualCap IV Pole Strips(Disinfectant Caps for Male Luers)Catheter Connections, Inc.2014-11-19840
K130975SWABCAP AND SWABFLUSHExcelsior Medical Corp.2013-12-242602
K123967CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERSCatheter Connections, Inc.2013-01-22270
K123065CATHETER CONNECTIONS DUALCAP SOLOCatheter Connections, Inc.2012-12-14741
K121171CUROS TIPIvera Medical, Inc.2012-11-262230
K113842CATHETER CONNECTIONS' DUALCAP SOLOCatheter Connections, Inc.2012-01-27300
K111992CUROS PORT PROTECTORIvera Medical, Inc.2012-01-121830
K112985CATHETER CONNECTIONS' DUALCAP DUOCatheter Connections, Inc.2011-11-09340
K110826CUROS PORT PROTECTORIvera Medical2011-06-23910
K093229CATHETER CONNECTIONS DUALCAPCatheter Connections, Inc.2010-04-081760
K083508SWABCAPExcelsior Medical Corp.2009-04-281530
K080466ALCOHOL PAD122 Corporation2008-10-212430
K080579EFFECTIV (TM) CAPHospira, Inc.2008-09-111920

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