Uroflowmeter
FDA product code EXY · Class II (moderate risk) · 21 CFR 876.1800 · Gastroenterology, Urology
16510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Life-Tech Intl., Inc. 3
- Life-Tech Instruments, Inc. 1
- Mct Medical, Inc. 1
- Eutectic Electronics, Inc. 1
- Biodan Medical Systems, Ltd. 1
- Diagnostic Ultrasound Corp. 1
- Laborie Medical Tech Corp. 1
- Fiberoptic Sensor Technlogies, Inc. 1
- Myo/Kinetic Systems, Inc. 1
- Synectics Medical, Inc. 1
- Dantec Medical, Inc. 1
- Albyn Medical , Ltd. 1
- W.O.M. World of Medicine GmbH 1
- Be Technologies, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142425 | UroflowmeterEXY · Traditional | Be Technologies, Inc. | 10/27/2014SE |
| K022721 | UropowerEXY · Traditional | W.O.M. World of Medicine AG | 08/26/2003SE |
| K971913 | GR100F Urine FlowmeterEXY · Traditional | Albyn Medical , Ltd. | 09/19/1997SE |
| K953999 | Dantec Da CapoEXY · Traditional | Dantec Medical, Inc. | 11/21/1995SE |
| K951442 | FlolabEXY · Traditional | Synectics Medical, Inc. | 08/24/1995SE |
| K944972 | Uro-Gram Cystomrtrogram with UroflowmetryEXY · Traditional | Myo/Kinetic Systems, Inc. | 03/08/1995SE |
| K945495 | 4-CHANNEL Urodynamic Monitor with Uro-Flo OptionEXY · Traditional | Fiberoptic Sensor Technlogies, Inc. | 02/09/1995SE |
| K941105 | Uorcap,Model Number Uds-UcapEXY · Traditional | Laborie Medical Tech, Inc. | 05/10/1994SE |
| K904557 | MicrofloEXY · Traditional | Life-Tech Intl., Inc. | 12/28/1990SE |
| K902408 | Diagnostic Ultrasound Ufs 1005EXY · Traditional | Diagnostic Ultrasound Corp. | 08/10/1990SE |
| K900770 | Home Urodata System(Tm)EXY · Traditional | Biodan Medical Systems, Ltd. | 06/08/1990SE |
| K894968 | UltracompactEXY · Traditional | Eutectic Electronics, Inc. | 11/08/1989SE |
| K880504 | MCT Medical Browne Uroscan UrodynamicEXY · Traditional | Mct Medical, Inc. | 06/17/1988SE |
| K873695 | Model 1859 Tumi/Pressure ModuleEXY · Traditional | Life-Tech Intl., Inc. | 01/27/1988SE |
| K872077 | Model 1858 Cavro/Pressure ModuleEXY · Traditional | Life-Tech Intl., Inc. | 08/27/1987SE |
| K770897 | Urodynamic InstrumentsEXY · Traditional | Life-Tech Instruments, Inc. | 06/03/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2777-2026 Class II | Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a…Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination… | Emano Metrics, Inc. | 05/29/2026Open, Classified |
| Z-1292-2022 Class II | ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlierDue to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform… | Dain Technology, Inc. (Subsidiary of… | 04/21/2022Terminated |