KSQ
8 FDA 510(k) clearances · Product code
51 daysmedian time to decision
67 days90th percentile
8clearances measured
FDA profile
- Official device name
- Device, Blood Mixing And Blood Weighing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.9195
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2000: 2
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 |
|---|---|---|
| HYCEL ROTOR-MIXER AND/OR MULTI (K842746) | R&D Systems, Inc. | 1984-08-17 |
| SEPCOR UNIT COLLECTION MONITOR (K820712) | Separation Science Corp. | 1982-05-07 |
| PLATELET AGITATOR (K812533) | Helmer Labs, Inc. | 1981-09-29 |
| MOBILE MATIC AUTOMATIC DONOR SCALE (K810617) | Lifeline Instruments, Inc. | 1981-04-07 |
| HEMATIC BLOOD MIXER (K802608) | Helmer Labs, Inc. | 1980-12-11 |
| ROYCO MODEL 951 CELL MIXER (K800104) | Royco Instruments | 1980-02-06 |
| PLATELET ROTATOR (K780189) | Travenol Laboratories, S.A. | 1978-03-30 |
| DONORMATIC (BLOOD COLLECTION DEVICE) (K760743) | Lifeline Instruments, Inc. | 1976-12-06 |
Track KSQ automatically
Every clearance here is in the API, with alerts when new ones post.