Class Class II
Intraosseous Infusion Needles (K250724)
Description
Intraosseous Infusion Needles by Spectrum Vascular, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250724
Clearance Date2025-07-30
Clearance TypeTraditional
Product CodeFMI
Regulation Number880.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250724
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. Intraosseous Infusion Needles (K250724) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160887 | Cook Intraosseous Infusion Needles | Cook Incorporated | 2016 |
Trace the full predicate network for K250724
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.