FFG · Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Gastroenterology, Urology · 21 CFR 876.1800 · Class 2
Overview
| Product Code | FFG |
|---|---|
| Device Name | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable |
| 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 (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893827 | PEAK FLOW RATE METER | Laytech Medical Co. | Aug 11, 1989 | SESE |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | Medical Engineering Corp. | Feb 8, 1989 | SESE |
| K850169 | ERIS URO-DIAGNOSTIC SYSTEM | Eris Medical Technology | Apr 22, 1985 | SESE |
| K844338 | 1URO-LOG HOME DIAGNOSTIC PACK | Epcom Medical Systems, Inc. | Feb 25, 1985 | SESE |
| K843442 | URINARY DRAINAGE CONTAINER 2013 WITH | Vital Metrics, Inc. | Jan 3, 1985 | SESE |
| K843441 | URINARY DRAINAGE CONTAINER 2012-WITH | Vital Metrics, Inc. | Jan 3, 1985 | SESE |
| K844030 | ACCUMETER ELECTRONIC URINEMETER SYSTEM | Travenol Laboratories, S.A. | Nov 20, 1984 | SESE |
| K843224 | UROPUMP MODEL 1711 | Life-Tech Intl., Inc. | Oct 19, 1984 | SESE |
| K833043 | UROMETER | Browne Medical, Inc. | Feb 4, 1984 | SESE |
| K813641 | VITAL METRICS URINE MONITORING SYSTEM | Vital Metrics, Inc. | Mar 1, 1982 | SESE |
| K813082 | UREOFIX 500 URINE MEASURING SYSTEM | Burron Medical Products, Inc. | Dec 31, 1981 | SESE |
| K811925 | UROFLOWMETER | C.R. Bard, Inc. | Sep 8, 1981 | SESE |
| K790894 | URITRON URINE METER | Joseph F. Daniel, C.R.N.A. | Sep 7, 1979 | SESE |
| K790365 | FLUID MEASUREMENT STAND | Hewlett-Packard Co. | May 11, 1979 | SESE |
| K790663 | MODEL 1750 STANDING URINAL | Life-Tech Instruments, Inc. | Apr 24, 1979 | SESE |
| K781597 | PM 2000 AUTOMATIC PATIENT CHAIR | Time Motion System Co. | Sep 27, 1978 | SESE |
| K771655 | CURITY PEAKOMETER | Kendall Research Center | Oct 14, 1977 | SESE |
Top Applicants
- Vital Metrics, Inc. — 3 clearances
- Browne Medical, Inc. — 1 clearance
- Burron Medical Products, Inc. — 1 clearance
- C.R. Bard, Inc. — 1 clearance
- Epcom Medical Systems, Inc. — 1 clearance
