EXR
9 FDA 510(k) clearances · Product code
34 daysmedian time to decision
337 days90th percentile
9clearances measured
FDA profile
- Official device name
- Urinometer, Mechanical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2001: 1 · 2014: 31 · 2015: 61
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| BARD URINE METER W/ BAG (K761083) | C.R. Bard, Inc. | 1977-01-26 |
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Every clearance here is in the API, with alerts when new ones post.