510(k) K251636 ยท FRN Pump, Infusion
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
| 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 K251636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Baxter Healthcare Corporation Brand Name: Spectrum IQ
Product Name: Infusion Pump
Model/Catalog Number: 3570009
Software Version: N/A
Product Description: Infusion Pump, one unit per carton
Component: N/A Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.