Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
FDA product code FFG · Class II (moderate risk) · 21 CFR 876.1800 · Gastroenterology, Urology
17510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Vital Metrics, Inc. 3
- Kendall Research Center 1
- Time Motion System Co. 1
- Life-Tech Instruments, Inc. 1
- Hewlett-Packard Co. 1
- Joseph F. Daniel, C.R.N.A. 1
- C.R. Bard, Inc. 1
- Burron Medical Products, Inc. 1
- Browne Medical, Inc. 1
- Life-Tech Intl., Inc. 1
- Travenol Laboratories, S.A. 1
- Epcom Medical Systems, Inc. 1
- Eris Medical Technology 1
- Medical Engineering Corp. 1
- Laytech Medical Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893827 | Peak Flow Rate MeterFFG · Traditional | Laytech Medical Co. | 08/11/1989SE |
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | Medical Engineering Corp. | 02/08/1989SE |
| K850169 | Eris Uro-Diagnostic SystemFFG · Traditional | Eris Medical Technology | 04/22/1985SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | Epcom Medical Systems, Inc. | 02/25/1985SE |
| K843442 | Urinary Drainage Container 2013 withFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K843441 | Urinary Drainage Container 2012-WITHFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K844030 | Accumeter Electronic Urinemeter SystemFFG · Traditional | Travenol Laboratories, S.A. | 11/20/1984SE |
| K843224 | Uropump Model 1711FFG · Traditional | Life-Tech Intl., Inc. | 10/19/1984SE |
| K833043 | UrometerFFG · Traditional | Browne Medical, Inc. | 02/04/1984SE |
| K813641 | Vital Metrics Urine Monitoring SystemFFG · Traditional | Vital Metrics, Inc. | 03/01/1982SE |
| K813082 | Ureofix 500 Urine Measuring SystemFFG · Traditional | Burron Medical Products, Inc. | 12/31/1981SE |
| K811925 | UroflowmeterFFG · Traditional | C.R. Bard, Inc. | 09/08/1981SE |
| K790894 | Uritron Urine MeterFFG · Traditional | Joseph F. Daniel, C.R.N.A. | 09/07/1979SE |
| K790365 | Fluid Measurement StandFFG · Traditional | Hewlett-Packard Co. | 05/11/1979SE |
| K790663 | Model 1750 Standing UrinalFFG · Traditional | Life-Tech Instruments, Inc. | 04/24/1979SE |
| K781597 | PM 2000 Automatic Patient ChairFFG · Traditional | Time Motion System Co. | 09/27/1978SE |
| K771655 | Curity PeakometerFFG · Traditional | Kendall Research Center | 10/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1047-2024 Class I | Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | Cardinal Health 200, LLC | 12/04/2023Open, Classified |