JCA
7 FDA 510(k) clearances · Product code
72 daysmedian time to decision
113 days90th percentile
7clearances measured
FDA profile
- Official device name
- Device, Bleeding Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6100
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1992: 1
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 |
|---|---|---|
| SIMPLATE PEDIATRIC (K911745) | Organon Teknika Corp. | 1991-08-09 |
| SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION (K911996) | International Technidyne Corp. | 1991-07-17 |
| Q.I.C. BLEEDING TIME DEVICE (K871318) | Helena Laboratories | 1987-06-10 |
| SURGICUTT - BLEEDING TIME DEVICE (K850542) | International Technidyne Corp. | 1985-03-01 |
| BLEEDING TIME DEVICE DISPOSABLE (K830645) | American Dade | 1983-03-17 |
| AUTOLET (K801815) | Ulster Scientific, Inc. | 1980-10-10 |
| SIMPLATE (K761250) | General Diagnostics | 1977-03-01 |
Track JCA automatically
Every clearance here is in the API, with alerts when new ones post.