UROFLOWMETER
FDA 510(k) clearance K811925 · decided 1981-09-08
Clearance details
- K-number
- K811925
- Device name
- UROFLOWMETER
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-02
- Decision date
- 1981-09-08
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- FFG
- Device class
- 2
- Regulation number
- 876.1800
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Warrendale, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PEAK FLOW RATE METER (K893827) | Laytech Medical Co. | 1989-08-11 |
| SURGITEK (R) UROFLOW SYSTEM (K883274) | Medical Engineering Corp. | 1989-02-08 |
| ERIS URO-DIAGNOSTIC SYSTEM (K850169) | Eris Medical Technology | 1985-04-22 |
| 1URO-LOG HOME DIAGNOSTIC PACK (K844338) | Epcom Medical Systems, Inc. | 1985-02-25 |
| URINARY DRAINAGE CONTAINER 2012-WITH (K843441) | Vital Metrics, Inc. | 1985-01-03 |
| URINARY DRAINAGE CONTAINER 2013 WITH (K843442) | Vital Metrics, Inc. | 1985-01-03 |
| ACCUMETER ELECTRONIC URINEMETER SYSTEM (K844030) | Travenol Laboratories, S.A. | 1984-11-20 |
| UROPUMP MODEL 1711 (K843224) | Life-Tech Intl., Inc. | 1984-10-19 |
| UROMETER (K833043) | Browne Medical, Inc. | 1984-02-04 |
| VITAL METRICS URINE MONITORING SYSTEM (K813641) | Vital Metrics, Inc. | 1982-03-01 |
| UREOFIX 500 URINE MEASURING SYSTEM (K813082) | Burron Medical Products, Inc. | 1981-12-31 |
| URITRON URINE METER (K790894) | Joseph F. Daniel, C.R.N.A. | 1979-09-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |