# K250724: Intraosseous Infusion Needles

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Vascular
- Decided: Jul 30, 2025 after 142 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913258 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160887: Cook Intraosseous Infusion Needles, Cook Incorporated (2016) Summary page 5.

## Indications for use
Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.

Source page: https://510kreport.com/device/K250724
Methodology: https://510kreport.com/methodology