BARD URINE METER W/ BAG
FDA 510(k) clearance K761083 · decided 1977-01-26
Clearance details
- K-number
- K761083
- Device name
- BARD URINE METER W/ BAG
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-11-19
- Decision date
- 1977-01-26
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- EXR
- Device class
- 2
- Regulation number
- 876.1800
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch C.R. Bard
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| URINARY DRAINAGE BAG (K934142) | Key Medical Services, Inc. | 1994-05-17 |
| URINE METER (K935578) | Puritas Health Care, Inc. | 1993-12-17 |
| KENDALL PEDIATRIC URINE METER (K911258) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1991-04-25 |
| UNOMETER 500 (K896732) | Unoplast A/S | 1990-11-02 |
| COMPRESS AND SKULLCAP, HEAD DRESSING (K870240) | Fraass Survival Systems, Inc. | 1987-02-20 |
| DOVER URINE METER (K771561) | Will Ross Co. | 1977-09-07 |
| URINE TESTER, MODEL NO. 707 (K770423) | Brother Scientific Products, Inc. | 1977-06-03 |
| URINE TESTER, MODEL 701 (K770939) | Brother Scientific Products, Inc. | 1977-06-03 |
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 |