Atlas FDA

FFG

17 FDA 510(k) clearances · Product code

78 daysmedian time to decision
151 days90th percentile
17clearances measured

FDA profile

Official device name
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1800
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2015: 103 · 2016: 96 · 2017: 34 · 2020: 92 · 2021: 109 · 2022: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PEAK FLOW RATE METER (K893827)Laytech Medical Co.1989-08-11
SURGITEK (R) UROFLOW SYSTEM (K883274)Medical Engineering Corp.1989-02-08
ERIS URO-DIAGNOSTIC SYSTEM (K850169)Eris Medical Technology1985-04-22
1URO-LOG HOME DIAGNOSTIC PACK (K844338)Epcom Medical Systems, Inc.1985-02-25
URINARY DRAINAGE CONTAINER 2012-WITH (K843441)Vital Metrics, Inc.1985-01-03
URINARY DRAINAGE CONTAINER 2013 WITH (K843442)Vital Metrics, Inc.1985-01-03
ACCUMETER ELECTRONIC URINEMETER SYSTEM (K844030)Travenol Laboratories, S.A.1984-11-20
UROPUMP MODEL 1711 (K843224)Life-Tech Intl., Inc.1984-10-19
UROMETER (K833043)Browne Medical, Inc.1984-02-04
VITAL METRICS URINE MONITORING SYSTEM (K813641)Vital Metrics, Inc.1982-03-01
UREOFIX 500 URINE MEASURING SYSTEM (K813082)Burron Medical Products, Inc.1981-12-31
UROFLOWMETER (K811925)C.R. Bard, Inc.1981-09-08
URITRON URINE METER (K790894)Joseph F. Daniel, C.R.N.A.1979-09-07
FLUID MEASUREMENT STAND (K790365)Hewlett-Packard Co.1979-05-11
MODEL 1750 STANDING URINAL (K790663)Life-Tech Instruments, Inc.1979-04-24
PM 2000 AUTOMATIC PATIENT CHAIR (K781597)Time Motion System Co.1978-09-27
CURITY PEAKOMETER (K771655)Kendall Research Center1977-10-14

Track FFG automatically

Every clearance here is in the API, with alerts when new ones post.