GKN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Timer, Clot, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2022: 54 · 2023: 120 · 2024: 54 · 2025: 51 · 2026: 29
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 |
|---|---|---|
| ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS (K953870) | Medtronic Vascular | 1995-10-31 |
| MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (K940426) | Medtronic Hemotec, Inc. | 1994-09-20 |
| MIL CM-II COAGULATION MACHINE (K913320) | Medical Innovations Corp. | 1992-06-16 |
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Every clearance here is in the API, with alerts when new ones post.