Class Class II

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636)

K251636 2025-07-28 Traditional
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Description

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) by Baxter Healthcare Corporation, an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251636
Clearance Date2025-07-28
Clearance TypeTraditional
Product CodeFRN
Regulation Number880.5725

Categories

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Predicate lineage for K251636

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. Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation2023

Trace the full predicate network for K251636

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.

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