Atlas FDA

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

Nexus Medical, LLC · Predicate Candidate Screening

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

140 daysmedian FDA review time
217 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142590All Safe Huber Safety Infusion SetNexus Medical, LLC2015-01-161230
K133351NEXUS NIS-6P LUER ACTIVATED DEVICENexus Medical, LLC2014-05-222030
K130879NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVENexus Medical, LLC2013-07-091020
K130416NEXUS TKO-6P LUER ACTIVATED DEVICENexus Medical, LLC2013-06-121130
K113398NEXUS TKO-6, LUER-ACTIVATED DEVICENexus Medical, LLC2012-04-181530
K092382NEXUS PRESSURE RATED EXTENSION SETSNexus Medical, LLC2010-04-262640
K092930NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCEDNexus Medical, LLC2010-03-101690
K092527NEXUS INJECTION SITE, MODEL NIS-8Nexus Medical, LLC2010-02-041700
K081123NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISNexus Medical, LLC2008-11-142070
K080976NEXUS I.V. FLUID TRANSFER DEVICENexus Medical, LLC2008-11-102170
K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC2006-12-151070
K053129NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5Nexus Medical, LLC2005-12-08300
K041861NEXUS INTRAVENOUS TUBING SETS (NIVTS)Nexus Medical, LLC2004-11-261400
K041844ALL SAFE HUBER SAFETY INFUSION SETSNexus Medical, LLC2004-09-03570
K041845NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4Nexus Medical, LLC2004-08-24470
K024363NEXUS INJECTION SITE (NIS), MODEL NIS-1Nexus Medical, LLC2003-02-19500

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