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

FFG — Predicate Candidate Screening

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

78 daysmedian FDA review time

151 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K893827	PEAK FLOW RATE METER	Laytech Medical Co.	1989-08-11	79
K883274	SURGITEK (R) UROFLOW SYSTEM	Medical Engineering Corp.	1989-02-08	189
K850169	ERIS URO-DIAGNOSTIC SYSTEM	Eris Medical Technology	1985-04-22	96
K844338	1URO-LOG HOME DIAGNOSTIC PACK	Epcom Medical Systems, Inc.	1985-02-25	109
K843441	URINARY DRAINAGE CONTAINER 2012-WITH	Vital Metrics, Inc.	1985-01-03	121
K843442	URINARY DRAINAGE CONTAINER 2013 WITH	Vital Metrics, Inc.	1985-01-03	121
K844030	ACCUMETER ELECTRONIC URINEMETER SYSTEM	Travenol Laboratories, S.A.	1984-11-20	36
K843224	UROPUMP MODEL 1711	Life-Tech Intl., Inc.	1984-10-19	64
K833043	UROMETER	Browne Medical, Inc.	1984-02-04	151
K813641	VITAL METRICS URINE MONITORING SYSTEM	Vital Metrics, Inc.	1982-03-01	61
K813082	UREOFIX 500 URINE MEASURING SYSTEM	Burron Medical Products, Inc.	1981-12-31	59
K811925	UROFLOWMETER	C.R. Bard, Inc.	1981-09-08	68
K790894	URITRON URINE METER	Joseph F. Daniel, C.R.N.A.	1979-09-07	122
K790365	FLUID MEASUREMENT STAND	Hewlett-Packard Co.	1979-05-11	78
K790663	MODEL 1750 STANDING URINAL	Life-Tech Instruments, Inc.	1979-04-24	18
K781597	PM 2000 AUTOMATIC PATIENT CHAIR	Time Motion System Co.	1978-09-27	12
K771655	CURITY PEAKOMETER	Kendall Research Center	1977-10-14	46

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