Data / Medical devices / Set, Tubing, Blood, With And Without Anti-Regurgitation Valve / United States
FDA-registered makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK). 5 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Product code
- FJK
- Country
- United States
Makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | Waltham, MA, United States | Complaint file establishment, Specification developer | 6 | May 31, 2023 | 0 | 2 | 0 | api.fda.gov |
| Outset Medical, Inc. | San Jose, CA, United States | Complaint file establishment, Specification developer | 2 | November 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | July 18, 2008 | 0 | 2 | 1 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Specification developer | 1 | December 24, 1998 | 0 | 1 | 0 | api.fda.gov |
| Reprocessing Products Corporation (RPC) | Tucson, AZ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | July 29, 1985 | 0 | 0 | 0 | api.fda.gov |
| Diality, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius USA Manufacturing, Inc. | Oregon, OH, United States | Manufacturer | 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.