Product Code: FFG FDA class 2 21 CFR 876.1800

Device, Urine Flow Rate Measuring, Non-Electrical, Disposable

Gastroenterology, Urology

The Non-Electrical, Disposable Urine Flow Rate Measuring Device is a single-use instrument used to quantify the flow rate of urine during voiding, providing diagnostic data for the assessment of urinary tract function. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FFG, regulated under 21 CFR 876.1800, within the Gastroenterology, Urology specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FFG
Device Class: FDA class 2
Regulation Number: 876.1800
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K893827	PEAK FLOW RATE METER	Aug 11, 1989	Substantially Equivalent	Laytech Medical Co.
K883274	SURGITEK (R) UROFLOW SYSTEM	Feb 08, 1989	Substantially Equivalent	Medical Engineering Corp.
K850169	ERIS URO-DIAGNOSTIC SYSTEM	Apr 22, 1985	Substantially Equivalent	Eris Medical Technology
K844338	1URO-LOG HOME DIAGNOSTIC PACK	Feb 25, 1985	Substantially Equivalent	Epcom Medical Systems, Inc.
K843442	URINARY DRAINAGE CONTAINER 2013 WITH	Jan 03, 1985	Substantially Equivalent	Vital Metrics, Inc.
K843441	URINARY DRAINAGE CONTAINER 2012-WITH	Jan 03, 1985	Substantially Equivalent	Vital Metrics, Inc.
K844030	ACCUMETER ELECTRONIC URINEMETER SYSTEM	Nov 20, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K843224	UROPUMP MODEL 1711	Oct 19, 1984	Substantially Equivalent	Life-Tech Intl., Inc.
K833043	UROMETER	Feb 04, 1984	Substantially Equivalent	Browne Medical, Inc.
K813641	VITAL METRICS URINE MONITORING SYSTEM	Mar 01, 1982	Substantially Equivalent	Vital Metrics, Inc.
K813082	UREOFIX 500 URINE MEASURING SYSTEM	Dec 31, 1981	Substantially Equivalent	Burron Medical Products, Inc.
K811925	UROFLOWMETER	Sep 08, 1981	Substantially Equivalent	C.R. Bard, Inc.
K790894	URITRON URINE METER	Sep 07, 1979	Substantially Equivalent	Joseph F. Daniel, C.R.N.A.
K790365	FLUID MEASUREMENT STAND	May 11, 1979	Substantially Equivalent	Hewlett-Packard Co.
K790663	MODEL 1750 STANDING URINAL	Apr 24, 1979	Substantially Equivalent	Life-Tech Instruments, Inc.
K781597	PM 2000 AUTOMATIC PATIENT CHAIR	Sep 27, 1978	Substantially Equivalent	Time Motion System Co.
K771655	CURITY PEAKOMETER	Oct 14, 1977	Substantially Equivalent	Kendall Research Center