Product code FFG
- Device name
- Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- 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 |
|---|---|---|---|
| K893827 | PEAK FLOW RATE METER | Laytech Medical Co. | 1989-08-11 |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | Medical Engineering Corp. | 1989-02-08 |
| K850169 | ERIS URO-DIAGNOSTIC SYSTEM | Eris Medical Technology | 1985-04-22 |
| K844338 | 1URO-LOG HOME DIAGNOSTIC PACK | Epcom Medical Systems, Inc. | 1985-02-25 |
| K843442 | URINARY DRAINAGE CONTAINER 2013 WITH | Vital Metrics, Inc. | 1985-01-03 |
| K843441 | URINARY DRAINAGE CONTAINER 2012-WITH | Vital Metrics, Inc. | 1985-01-03 |
| K844030 | ACCUMETER ELECTRONIC URINEMETER SYSTEM | Travenol Laboratories, S.A. | 1984-11-20 |
| K843224 | UROPUMP MODEL 1711 | Life-Tech Intl., Inc. | 1984-10-19 |
| K833043 | UROMETER | Browne Medical, Inc. | 1984-02-04 |
| K813641 | VITAL METRICS URINE MONITORING SYSTEM | Vital Metrics, Inc. | 1982-03-01 |
| K813082 | UREOFIX 500 URINE MEASURING SYSTEM | Burron Medical Products, Inc. | 1981-12-31 |
| K811925 | UROFLOWMETER | C.R. Bard, Inc. | 1981-09-08 |
| K790894 | URITRON URINE METER | Joseph F. Daniel, C.R.N.A. | 1979-09-07 |
| K790365 | FLUID MEASUREMENT STAND | Hewlett-Packard Co. | 1979-05-11 |
| K790663 | MODEL 1750 STANDING URINAL | Life-Tech Instruments, Inc. | 1979-04-24 |
| K781597 | PM 2000 AUTOMATIC PATIENT CHAIR | Time Motion System Co. | 1978-09-27 |
| K771655 | CURITY PEAKOMETER | Kendall Research Center | 1977-10-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344156269 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-05 |
| 10197344157884 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-05 |
| 10192253028423 | Dover | Cardinal Health 200, LLC | 2025-04-01 |
| 10192253028980 | Dover | Cardinal Health 200, LLC | 2025-01-15 |
| 10888277678415 | Medline | MEDLINE INDUSTRIES, INC. | 2021-09-16 |
| 10888277678392 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-05 |
| 10080196998401 | Medline | MEDLINE INDUSTRIES, INC. | 2020-12-23 |
| 10884389121191 | Medline | MEDLINE INDUSTRIES, INC. | 2020-12-23 |
| 10704411013075 | AMSure® Urine Meter Drainage Bag | AMSINO INTERNATIONAL, INC. | 2020-10-16 |
| 10884389119495 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10888277136946 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196749577 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10884521029583 | Dover | Cardinal Health 200, LLC | 2016-09-28 |
| 10884521067011 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 20884521067001 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10884521066991 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10884521067028 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10884521069060 | Dover | Cardinal Health, Inc. | 2016-09-24 |
| 20884521029597 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 20884521057736 | Dover | Cardinal Health, Inc. | 2016-09-24 |
| 10884521066984 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10884521066977 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10884521066960 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10884521051393 | Dover | Cardinal Health, Inc. | 2016-09-24 |
| 10884521029644 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10884521029620 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10884521004511 | Dover | Cardinal Health, Inc. | 2016-09-24 |
| 10884521004498 | Dover | Cardinal Health, Inc. | 2016-09-24 |
| 10884521002180 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 10704411005490 | AMSure® Urine Meter Drainage Bag | AMSINO INTERNATIONAL, INC. | 2016-09-23 |