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

Cordis Webster, Inc. — Predicate Candidate Screening

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

93 daysmedian FDA review time

408 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K992965	CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085	Cordis Webster, Inc.	1999-11-26	85	0
K991531	CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-	Cordis Webster, Inc.	1999-10-04	154	0
K982740	CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHAN	Cordis Webster, Inc.	1998-08-28	22	0
K982415	CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-	Cordis Webster, Inc.	1998-08-10	28	0
K980961	CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S	Cordis Webster, Inc.	1998-05-28	73	0
K970264	CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM	Cordis Webster, Inc.	1997-10-28	278	0
K953663	CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	Cordis Webster, Inc.	1996-09-18	408	0
K955817	CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER	Cordis Webster, Inc.	1996-03-25	90	0
K954390	CORDIS WESTER STAR CATHETER	Cordis Webster, Inc.	1995-12-21	93	0
K953768	CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	Cordis Webster, Inc.	1995-11-22	100	4

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