Uroflowmeter
The uroflowmeter is a diagnostic device that measures the rate and volume of urine flow during voluntary voiding, used to assess lower urinary tract function and diagnose conditions such as bladder outlet obstruction, urethral stricture, or detrusor underactivity. It is classified as FDA Class 2, indicating moderate risk, and is subject to special controls. The product code is EXY, regulated under 21 CFR 876.1800 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
Basic Information
- Product Code
- EXY
- Device Class
- FDA class 2
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142425 | Uroflowmeter | Oct 27, 2014 | Substantially Equivalent | Be Technologies, Inc. |
| K022721 | UROPOWER | Aug 26, 2003 | Substantially Equivalent | W.O.M. World of Medicine AG |
| K971913 | GR100F URINE FLOWMETER | Sep 19, 1997 | Substantially Equivalent | Albyn Medical , Ltd. |
| K953999 | DANTEC DA CAPO | Nov 21, 1995 | Substantially Equivalent | Dantec Medical, Inc. |
| K951442 | FLOLAB | Aug 24, 1995 | Substantially Equivalent | Synectics Medical, Inc. |
| K944972 | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | Mar 08, 1995 | Substantially Equivalent | Myo/Kinetic Systems, Inc. |
| K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | Feb 09, 1995 | Substantially Equivalent | Fiberoptic Sensor Technlogies, Inc. |
| K941105 | UORCAP,MODEL NUMBER UDS-UCAP | May 10, 1994 | Substantially Equivalent | Laborie Medical Tech, Inc. |
| K904557 | MICROFLO | Dec 28, 1990 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K902408 | DIAGNOSTIC ULTRASOUND UFS 1005 | Aug 10, 1990 | Substantially Equivalent | Diagnostic Ultrasound Corp. |
| K900770 | HOME URODATA SYSTEM(TM) | Jun 08, 1990 | Substantially Equivalent | Biodan Medical Systems, Ltd. |
| K894968 | ULTRACOMPACT | Nov 08, 1989 | Substantially Equivalent | Eutectic Electronics, Inc. |
| K880504 | MCT MEDICAL BROWNE UROSCAN URODYNAMIC | Jun 17, 1988 | Substantially Equivalent | Mct Medical, Inc. |
| K873695 | MODEL 1859 TUMI/PRESSURE MODULE | Jan 27, 1988 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K872077 | MODEL 1858 CAVRO/PRESSURE MODULE | Aug 27, 1987 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K770897 | URODYNAMIC INSTRUMENTS | Jun 03, 1977 | Substantially Equivalent | Life-Tech Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.