SIGMA Spectrum Infusion Pump with Master Drug Library (K251640)
Description
SIGMA Spectrum Infusion Pump with Master Drug Library by Baxter Healthcare Corporation, an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251640
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SIGMA Spectrum Infusion Pump with Master Drug Library (K251640) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2023 |
Trace the full predicate network for K251640
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.