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

FCN · Predicate Candidate Screening

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

87 daysmedian FDA review time

1027 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K951443	STANDARD FOLEY SYSTEM PAK	Trinity Laboratories, Inc.	1995-06-15	78
K945258	CATCO URINARY COLLECTION KIT	Catco Medical, Inc.	1995-02-16	111
K915166	MICROCYCLER	Medical Inventors Corp., Inc.	1994-09-07	1027
K922346	FEMALE URINE SAMPLING DEVICE	Mentor Corp.	1992-08-14	87
K890096	BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG	Medical Inventors Corp., Inc.	1989-07-14	185
K883886	DOUBLE CLOSED URINARY DRAINAGE SYSTEM	Knight Medical, Inc.	1988-12-19	97
K883610	LAKE FOLEY CATHETERIZATION TRAY	Lake Medical Products, Inc.	1988-10-12	51
K780134	URINARY DRAINAGE MONITORING SYSTEM	Medical Devices, Inc.	1978-02-02	9
K772133	URINE SPECIMEN COLLECTING DEVICE	Kendall Research Center	1977-11-28	14
K771210	UROGARD URINARY DRAINAGE BAG	Terumo America, Inc.	1977-07-11	6

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