EXY
16 FDA 510(k) clearances · Product code
93 daysmedian time to decision
148 days90th percentile
16clearances measured
FDA profile
- Official device name
- Uroflowmeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Uroflowmeter (K142425) | Be Technologies, Inc. | 2014-10-27 |
| UROPOWER (K022721) | W.O.M. World of Medicine AG | 2003-08-26 |
| GR100F URINE FLOWMETER (K971913) | Albyn Medical , Ltd. | 1997-09-19 |
| DANTEC DA CAPO (K953999) | Dantec Medical, Inc. | 1995-11-21 |
| FLOLAB (K951442) | Synectics Medical, Inc. | 1995-08-24 |
| URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (K944972) | Myo/Kinetic Systems, Inc. | 1995-03-08 |
| 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (K945495) | Fiberoptic Sensor Technlogies, Inc. | 1995-02-09 |
| UORCAP,MODEL NUMBER UDS-UCAP (K941105) | Laborie Medical Tech, Inc. | 1994-05-10 |
| MICROFLO (K904557) | Life-Tech Intl., Inc. | 1990-12-28 |
| DIAGNOSTIC ULTRASOUND UFS 1005 (K902408) | Diagnostic Ultrasound Corp. | 1990-08-10 |
| HOME URODATA SYSTEM(TM) (K900770) | Biodan Medical Systems, Ltd. | 1990-06-08 |
| ULTRACOMPACT (K894968) | Eutectic Electronics, Inc. | 1989-11-08 |
| MCT MEDICAL BROWNE UROSCAN URODYNAMIC (K880504) | Mct Medical, Inc. | 1988-06-17 |
| MODEL 1859 TUMI/PRESSURE MODULE (K873695) | Life-Tech Intl., Inc. | 1988-01-27 |
| MODEL 1858 CAVRO/PRESSURE MODULE (K872077) | Life-Tech Intl., Inc. | 1987-08-27 |
| URODYNAMIC INSTRUMENTS (K770897) | Life-Tech Instruments, Inc. | 1977-06-03 |
Track EXY automatically
Every clearance here is in the API, with alerts when new ones post.