Atlas FDA

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

Rex Medical, L.P. · Predicate Candidate Screening

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

107 daysmedian FDA review time
150 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212351Revolution Peripheral Atherectomy SystemRex Medical, L.P.2021-12-151390
K191419Revolution Peripheral Atherectomy System, Revolution PeripheRex Medical, L.P.2019-09-121070
K173389Rex Medical Aspiration PumpRex Medical, L.P.2018-01-30920
K143405Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P.2015-04-161390
K141617CLEANER ROTATIONAL THROMBECTOMY SYSTEMRex Medical, L.P.2014-11-141500
K133243OPTION ELITE VENA CAVA FILTER SYSTEMRex Medical, L.P.2013-12-17562
K060904CLEANER ROTATIONAL THROMBECTOMY SYSTEMRex Medical, L.P.2006-04-28250
K042399MODIFICATION TO SHORT INTRODUCER SHEATHRex Medical, L.P.2004-12-171050

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