Product code EXY
- Device name
- Uroflowmeter
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1800
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142425 | Uroflowmeter | Be Technologies, Inc. | 2014-10-27 |
| K022721 | UROPOWER | W.O.M. World of Medicine AG | 2003-08-26 |
| K971913 | GR100F URINE FLOWMETER | Albyn Medical , Ltd. | 1997-09-19 |
| K953999 | DANTEC DA CAPO | Dantec Medical, Inc. | 1995-11-21 |
| K951442 | FLOLAB | Synectics Medical, Inc. | 1995-08-24 |
| K944972 | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | Myo/Kinetic Systems, Inc. | 1995-03-08 |
| K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | Fiberoptic Sensor Technlogies, Inc. | 1995-02-09 |
| K941105 | UORCAP,MODEL NUMBER UDS-UCAP | Laborie Medical Tech, Inc. | 1994-05-10 |
| K904557 | MICROFLO | Life-Tech Intl., Inc. | 1990-12-28 |
| K902408 | DIAGNOSTIC ULTRASOUND UFS 1005 | Diagnostic Ultrasound Corp. | 1990-08-10 |
| K900770 | HOME URODATA SYSTEM(TM) | Biodan Medical Systems, Ltd. | 1990-06-08 |
| K894968 | ULTRACOMPACT | Eutectic Electronics, Inc. | 1989-11-08 |
| K880504 | MCT MEDICAL BROWNE UROSCAN URODYNAMIC | Mct Medical, Inc. | 1988-06-17 |
| K873695 | MODEL 1859 TUMI/PRESSURE MODULE | Life-Tech Intl., Inc. | 1988-01-27 |
| K872077 | MODEL 1858 CAVRO/PRESSURE MODULE | Life-Tech Intl., Inc. | 1987-08-27 |
| K770897 | URODYNAMIC INSTRUMENTS | Life-Tech Instruments, Inc. | 1977-06-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860009800670 | Glean | Bright Uro, Inc | 2026-07-29 |
| 00860009800663 | Glean | Bright Uro, Inc | 2026-07-29 |
| 00199874903484 | Emano Flow | Emano Metrics Inc. | 2026-06-16 |
| 00086000980061 | Glean | Bright Uro, Inc | 2025-09-23 |
| 00860010862209 | CarePath System | I/O Urology Corp. | 2024-06-20 |
| 00890477000364 | EasyFlo Console | SRS Medical Systems, Inc. | 2023-04-26 |
| 00850019755114 | Accuryn SmartFoley IAP UO Temp Tray System 14Fr | POTRERO MEDICAL, INC. | 2023-03-30 |
| 00850019755107 | Accuryn SmartFoley IAP UO Temp Tray System 12Fr | POTRERO MEDICAL, INC. | 2023-03-30 |
| 00860412001503 | Stream Dx | ZIEN MEDICAL TECHNOLOGIES, INC. | 2023-03-28 |
| 00860412001565 | Stream Dx | ZIEN MEDICAL TECHNOLOGIES, INC. | 2023-03-28 |
| 00850019755008 | Accuryn Temperature Cable | POTRERO MEDICAL, INC. | 2022-10-19 |
| 00850019755145 | Accuryn SmartFoley UO Temp Tray System 16Fr | POTRERO MEDICAL, INC. | 2021-09-29 |
| 00850019755121 | Accuryn SmartFoley IAP UO Temp Tray System 16Fr | POTRERO MEDICAL, INC. | 2021-09-29 |
| 10860003114701 | CarePath | Cleartrac Technologies, LLC | 2021-06-30 |
| 10860003114718 | CarePath | Cleartrac Technologies, LLC | 2021-06-30 |
| B408IF20 | iUFlow | KESEM HEALTH PTY LTD | 2020-07-31 |
| 00890477000227 | EasyFlo Base Unit | SRS Medical Systems, Inc. | 2018-06-25 |
| 00890477000197 | EasyFlo Scale | SRS Medical Systems, Inc. | 2018-06-25 |
| 00852423006387 | WiFLOW | PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE | 2017-02-14 |
| 00852423006301 | N/A | PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE | 2016-09-26 |
| 00852423006035 | Pathway | PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE | 2016-09-26 |
| 08717775955597 | Urodyn+ with spinning disc | Medical Measurement Systems B.V. | 2016-09-23 |
| 10627825005965 | Urocap IV Light | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825005958 | Urocap IV Light | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 00627825005944 | Urocap IV Light | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 00627825005937 | Urocap IV Light | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 00627825005777 | Urocap III | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 00627825005760 | Urocap III | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 00627825003629 | Urocap V | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 00627825003599 | Urocap IV | Laborie Medical Technologies Canada ULC | 2016-09-21 |