EXY · Uroflowmeter
Gastroenterology, Urology · 21 CFR 876.1800 · Class 2
Overview
| Product Code | EXY |
|---|---|
| Device Name | Uroflowmeter |
| 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 (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142425 | Uroflowmeter | Be Technologies, Inc. | Oct 27, 2014 | SESE |
| K022721 | UROPOWER | W.O.M. World of Medicine AG | Aug 26, 2003 | SESE |
| K971913 | GR100F URINE FLOWMETER | Albyn Medical , Ltd. | Sep 19, 1997 | SESE |
| K953999 | DANTEC DA CAPO | Dantec Medical, Inc. | Nov 21, 1995 | SESE |
| K951442 | FLOLAB | Synectics Medical, Inc. | Aug 24, 1995 | SESE |
| K944972 | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | Myo/Kinetic Systems, Inc. | Mar 8, 1995 | SESE |
| K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | Fiberoptic Sensor Technlogies, Inc. | Feb 9, 1995 | SESE |
| K941105 | UORCAP,MODEL NUMBER UDS-UCAP | Laborie Medical Tech, Inc. | May 10, 1994 | SESE |
| K904557 | MICROFLO | Life-Tech Intl., Inc. | Dec 28, 1990 | SESE |
| K902408 | DIAGNOSTIC ULTRASOUND UFS 1005 | Diagnostic Ultrasound Corp. | Aug 10, 1990 | SESE |
| K900770 | HOME URODATA SYSTEM(TM) | Biodan Medical Systems, Ltd. | Jun 8, 1990 | SESE |
| K894968 | ULTRACOMPACT | Eutectic Electronics, Inc. | Nov 8, 1989 | SESE |
| K880504 | MCT MEDICAL BROWNE UROSCAN URODYNAMIC | Mct Medical, Inc. | Jun 17, 1988 | SESE |
| K873695 | MODEL 1859 TUMI/PRESSURE MODULE | Life-Tech Intl., Inc. | Jan 27, 1988 | SESE |
| K872077 | MODEL 1858 CAVRO/PRESSURE MODULE | Life-Tech Intl., Inc. | Aug 27, 1987 | SESE |
| K770897 | URODYNAMIC INSTRUMENTS | Life-Tech Instruments, Inc. | Jun 3, 1977 | SESE |
Top Applicants
- Life-Tech Intl., Inc. — 3 clearances
- Albyn Medical , Ltd. — 1 clearance
- Be Technologies, Inc. — 1 clearance
- Biodan Medical Systems, Ltd. — 1 clearance
- Dantec Medical, Inc. — 1 clearance
