510(k) K252015 ยท FRN Pump, Infusion
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
| Applicant | Koru Medical Systems, Inc., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 28, 2026 |
| Received | Jun 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252015
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.