# K160887: Cook Intraosseous Infusion Needles

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Jul 26, 2016 after 117 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: 1 generation back to K913258 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913258: Disposable Introsseous Infusion Needles, Cook, Inc. (1992) Summary page 4.

## Most influential descendants
- K250724: Intraosseous Infusion Needles (2025), 0 descendants of its own

## Indications for use
Cook 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/K160887
Methodology: https://510kreport.com/methodology