510(k) K251640 ยท FRN Pump, Infusion
SIGMA Spectrum Infusion Pump with Master Drug Library
| Applicant | Baxter Healthcare Corporation, Deerfield Lake IL, US |
| Decision | Substantially Equivalent, Jul 28, 2025 |
| Received | May 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | Baxter Healthcare Corporation SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.