KZL
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, Warming. Blood And Plasma
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9205
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2021: 71 · 2022: 102 · 2023: 106 · 2024: 57 · 2025: 78 · 2026: 37
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 |
|---|---|---|
| ROCKING/CIRCULATING CYTO-THERM II 3570 (K813489) | Cryosan, Inc. | 1982-03-04 |
| CIRCULATING CYTO-THERMS (K812311) | Cryosan, Inc. | 1981-09-16 |
| FLO TEM (FLUID WARNER) (K800699) | Chroma Products, Inc. | 1980-05-08 |
| MODEL 114 TREONIC H150 HAEMOHEATER (K790936) | Vickers America Medical Corp. | 1979-09-04 |
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Every clearance here is in the API, with alerts when new ones post.