EXR · Urinometer, Mechanical
Gastroenterology, Urology · 21 CFR 876.1800 · Class 2
Overview
| Product Code | EXR |
|---|---|
| Device Name | Urinometer, Mechanical |
| Regulation | 21 CFR 876.1800 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Special Controls
*Classification.* (1) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934142 | URINARY DRAINAGE BAG | Key Medical Services, Inc. | May 17, 1994 | SESE |
| K935578 | URINE METER | Puritas Health Care, Inc. | Dec 17, 1993 | SESE |
| K911258 | KENDALL PEDIATRIC URINE METER | Kendall Healthcare Products Co. Div.Of Tyco Health | Apr 25, 1991 | SESE |
| K896732 | UNOMETER 500 | Unoplast A/S | Nov 2, 1990 | SESE |
| K870240 | COMPRESS AND SKULLCAP, HEAD DRESSING | Fraass Survival Systems, Inc. | Feb 20, 1987 | SESE |
| K771561 | DOVER URINE METER | Will Ross Co. | Sep 7, 1977 | SESE |
| K770939 | URINE TESTER, MODEL 701 | Brother Scientific Products, Inc. | Jun 3, 1977 | SESE |
| K770423 | URINE TESTER, MODEL NO. 707 | Brother Scientific Products, Inc. | Jun 3, 1977 | SESE |
| K761083 | BARD URINE METER W/ BAG | C.R. Bard, Inc. | Jan 26, 1977 | SESE |
Top Applicants
- Brother Scientific Products, Inc. — 2 clearances
- Will Ross Co. — 1 clearance
- Unoplast A/S — 1 clearance
- Puritas Health Care, Inc. — 1 clearance
- Key Medical Services, Inc. — 1 clearance
