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

Ev3 Corporation — Predicate Candidate Screening

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

30 daysmedian FDA review time

888 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K051379	PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT	Ev3 Corporation	2005-06-17	21	0
K050725	PROTEGE GPS SELF-EXPANDING NITINOL STENT	Ev3 Corporation	2005-04-20	30	1
K021096	X-SIZER CATHETER SYSTEM	Ev3 Corporation	2004-09-08	888	2
K031864	NITREX NITINOL GUIDEWIRE	Ev3 Corporation	2003-06-24	8	0
K024021	NITREX NITINOL GUIDEWIRE	Ev3 Corporation	2003-01-24	50	0

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