Data / Medical devices / Separator, Automated, Blood Cell And Plasma, Therapeutic / United States
FDA-registered makers of Separator, Automated, Blood Cell And Plasma, Therapeutic in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN). 4 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Product code
- LKN
- Country
- United States
Makers of Separator, Automated, Blood Cell And Plasma, Therapeutic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Terumo BCT, Inc.. | Lakewood, CO, United States | Manufacturer | 13 | February 5, 2019 | 0 | 5 | 0 | api.fda.gov |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 6 | November 13, 2019 | 0 | 3 | 0 | api.fda.gov |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer | 2 | November 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 1 | June 4, 1996 | 0 | 0 | 0 | api.fda.gov |
| Nxstage Medical, Inc. | Lawrence, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.