KSB
6 FDA 510(k) clearances · Product code
78 daysmedian time to decision
367 days90th percentile
6clearances measured
FDA profile
- Official device name
- Set, Transfer (Blood/Plasma)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9875
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1996: 2 · 1998: 1 · 1999: 1 · 2000: 2 · 2005: 7 · 2017: 26
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 |
|---|---|---|
| Kawasumi Laboratories Blood Drawing Kit (BDK) System (K172957) | Kawasumi Laboratories, Inc. | 2018-09-28 |
| KAWASUMI LABORATORY BLOOD DRAWING KIT (K001043) | Kawasumi Laboratories America, Inc. | 2000-05-19 |
| ALPHA PLASMA TRANSFER SET (K820447) | Alpha Therapeutic Corp. | 1982-04-14 |
| SUPER-SPIKE TRANSFER SET (K802940) | Geneva Laboratories, Inc. | 1981-01-15 |
| FLU-VEN TK-2 (K791130) | Venospital, Inc. | 1979-09-04 |
| FLU VEN TR-1 (K791131) | Venospital, Inc. | 1979-09-04 |
Track KSB automatically
Every clearance here is in the API, with alerts when new ones post.