Data / Medical devices / Separator, Automated, Blood Cell And Plasma, Therapeutic
Separator, Automated, Blood Cell And Plasma, Therapeutic (LKN): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN, Class U). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on November 13, 2019, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Mexico | 3 |
| Dominican Republic | 1 |
| Germany | 1 |
| Costa Rica | 1 |
Makers of Separator, Automated, Blood Cell And Plasma, Therapeutic
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Fenwal International, Inc. | HAINA San Cristobal, Dominican Republic | Manufacturer | 3 | December 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer | 2 | November 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Hemocare GMBH | Friedberg Hesse, Germany | Exporter to the US, Specification developer | 1 | September 5, 2006 | 0 | 0 | 0 | api.fda.gov |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 1 | June 4, 1996 | 0 | 0 | 0 | api.fda.gov |
| Haemonetics Mexico Manufacturing S. de R.L. de C.V. | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 1 | June 4, 1996 | 0 | 0 | 0 | api.fda.gov |
| Medimexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 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 | |
| TFB Manufacturing SRL | La Lima, Guadalupe Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venusa de Mexico S. de R.L de C.V | CIUDAD JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 13, 2019. 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.