KSE
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Refrigerator, Freezer, Blood Storage
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9700
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2002: 5 · 2003: 78 · 2004: 64 · 2005: 61 · 2006: 127 · 2008: 32
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 |
|---|---|---|
| MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 (K884436) | Harris Mfg. Co. | 1988-12-02 |
| SEPCOR TEMPERATURE MONITOR (K813327) | Separation Science Corp. | 1981-12-31 |
| HEMOTEMP TM (K802319) | Marion Laboratories, Inc. | 1980-10-10 |
| MONITEMP BLOOD PACK TEMP. MONITOR (K800667) | Liquid Crystal Products, Inc. | 1980-04-16 |
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Every clearance here is in the API, with alerts when new ones post.