510(k) K250523 ยท FKX System, Peritoneal, Automatic Delivery
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-
| Applicant | Simergent, LLC, Oklahoma City OK, US |
| Decision | Substantially Equivalent, Oct 2, 2025 |
| Received | Feb 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250523
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.