Atlas FDA

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

NFK · Predicate Candidate Screening

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

85 daysmedian FDA review time
106 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K101261CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 558700C.R. Bard, Inc.2010-07-29850
K092797ACUTE AND CHRONIC CATHETER REPAIR KITKendall2009-11-19690
K063446CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 558700C.R. Bard, Inc.2006-12-15300
K062435REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERSSpire Biomedical, Inc.2006-12-051060
K030442CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 558700C.R. Bard, Inc.2003-07-211600
K022644RETRO REPAIR KIT, MODEL PRRK5Spire Biomedical, Inc.2002-11-06900
K022570MEDCOMP REPAIR KIT, MODEL ASPCRPKMedcomp2002-10-31900
K022561CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 558700C.R. Bard, Inc.2002-08-23210
K020430DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)Diatek, Inc.2002-05-09900
K011015CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 558700C.R. Bard, Inc.2001-06-22790
K011576MEDCOMP ASH SPLITMedical Components, Inc.2001-06-21300

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