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

EZC · Predicate Candidate Screening

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

170 daysmedian FDA review time

205 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K222279	Rusch Intermittent Urethral Catheters	Teleflex Medical	2022-08-29	31	0
K173596	Rusch Intermittent Urethral Catheters	Teleflex Medical	2018-01-29	69	0
K946282	UNIVERSAL URETHRAL CATHETER	Louisville Laboratories, Inc.	1995-03-31	94	0
K913341	BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER	C.R. Bard, Inc.	1992-01-27	185	0
K910846	BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF	C.R. Bard, Inc.	1991-08-16	170	8
K910197	HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS	C.R. Bard, Inc.	1991-08-09	205	0
K910195	BARD HYDROGEL-COATED FOLEY CATHETERS	C.R. Bard, Inc.	1991-08-09	205	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