Product Code: EXR FDA class 2 21 CFR 876.1800

Urinometer, Mechanical

Gastroenterology, Urology

The mechanical urinometer is a device used to measure the specific gravity of urine by determining the buoyancy of a float in a urine sample, providing a simple assessment of urinary concentration and renal concentrating ability. It is classified as FDA Class 2, representing moderate risk, and is subject to special controls. The product code is EXR, regulated under 21 CFR 876.1800 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

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

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

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 9 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K934142	URINARY DRAINAGE BAG	May 17, 1994	Substantially Equivalent	Key Medical Services, Inc.
K935578	URINE METER	Dec 17, 1993	Substantially Equivalent	Puritas Health Care, Inc.
K911258	KENDALL PEDIATRIC URINE METER	Apr 25, 1991	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K896732	UNOMETER 500	Nov 02, 1990	Substantially Equivalent	Unoplast A/S
K870240	COMPRESS AND SKULLCAP, HEAD DRESSING	Feb 20, 1987	Substantially Equivalent	Fraass Survival Systems, Inc.
K771561	DOVER URINE METER	Sep 07, 1977	Substantially Equivalent	Will Ross Co.
K770939	URINE TESTER, MODEL 701	Jun 03, 1977	Substantially Equivalent	Brother Scientific Products, Inc.
K770423	URINE TESTER, MODEL NO. 707	Jun 03, 1977	Substantially Equivalent	Brother Scientific Products, Inc.
K761083	BARD URINE METER W/ BAG	Jan 26, 1977	Substantially Equivalent	C.R. Bard, Inc.