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

EYZ — Predicate Candidate Screening

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

145 daysmedian FDA review time

242 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K964219	ZIP CONDOM CATHETER	Goulter Medical, Inc.	1997-08-11	293
K961906	UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,	Spectrum Medsystems Corp.	1996-11-19	187
K952780	URINARY GEL DRAINAGE SYSTEM	P.A.M., Inc.	1995-12-12	179
K951597	URINARY DRAINAGE BAG	Key Medical Services, Inc.	1995-08-04	119
K942753	ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER	Researched, Novel Medical Devices (Rn/Md)	1994-11-02	145
K933126	COMFORTCARE SYSTEM	Patsy J. Trisler, J.D.	1994-02-25	242
K930556	NIGHT URINARY DRAINAGE BEDSIDE BAG	Ezmt Valve Co., Inc.	1993-05-14	100
K896695	DYNA-FLO URINARY DRAINAGE BAG	Medline Industries, Inc.	1990-05-02	155
K901000	URO TEX URINALS	Sierra Laboratories, Inc.	1990-03-26	24
K891178	TECNOL SECURE-ALL TUBE HOLDER	Tecnol New Jersey Wound Care, Inc.	1989-05-23	78
K890465	CLOSED SYSTEM URINARY DRAINAGE BAG	Cypress Medical Products, Ltd.	1989-05-23	112
K882714	URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450	Lsl Industries, Inc.	1989-01-31	214
K780267	CATH TRAY W/OUT CATHETER	Latex Ind., Inc.	1978-02-24	7
K772113	URINARY DRAINAGE BAG 2D9017	Travenol Laboratories, S.A.	1977-11-16	9

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