Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

EXI · Predicate Candidate Screening

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

100 daysmedian FDA review time

272 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K971499	FEMALE EXTERNAL URINARY COLLECTION POUCH	Mediquest, Inc.	1997-08-28	125
K970443	HOLLISTER RETRACTED PENIS POUCH	Hollister, Inc.	1997-02-25	20
K963950	BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE	Bioderm, Inc.	1997-01-10	100
K931277	HOLLISTER PREMIUM URINE COLLECTOR	Hollister, Inc.	1993-06-23	107
K924755	CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION	Convatec, A Division of E.R. Squibb & Sons	1993-06-22	272
K915246	CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)	Coloplast A/S	1992-02-05	82
K915616	URIHESIVE STRIP	Convatec, A Division of E.R. Squibb & Sons	1992-01-23	38

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