Data / Medical devices / Set, Transfer (Blood/Plasma)
Set, Transfer (Blood/Plasma) (KSB): 11 FDA-registered makers in 7 countries
11 establishments in 7 countries are registered with the FDA to make Set, Transfer (Blood/Plasma) (product code KSB, Class 2, 21 CFR 864.9875). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on September 28, 2018, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSB
- Device class
- 2
- Regulation
- 864.9875
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Thailand | 1 |
| Dominican Republic | 1 |
| Germany | 1 |
| Japan | 1 |
| Singapore | 1 |
| Sweden | 1 |
Makers of Set, Transfer (Blood/Plasma)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kawasumi Laboratories (thailand) Co., Ltd. | CHOK CHAI Nakhon Ratchasima, Thailand | Manufacturer | 1 | September 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Charter Medical, LLC | Winston Salem, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal International, Inc. | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Hemocare GMBH | Friedberg Hesse, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesisbps LLC | Mahwah, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GVS TM, Inc. | Covina, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kofu Factory Of Terumo Corp. | NAKAKOMA-GUN Yamanashi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Racer Technology Pte Ltd | SINGAPORE South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina-Sci AB | SJALEVAD Vasternorrland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo BCT, Inc.. | Lakewood, CO, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 28, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.