# K913258: Disposable Introsseous Infusion Needles

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Mar 4, 1992 after 225 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
No predicates in its family tree.
22 later devices descend from it; 6 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022415: Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST (2002), 17 descendants of its own
- K043490: PD-IO Disposable Intraosseous Infusion Needle (2005), 16 descendants of its own
- K052195: EZ-Mio Manual Driver (2005), 13 descendants of its own
- K970380: F.a.S.T. 1 Intraosseous Infusion System (1997), 7 descendants of its own
- K072487: FAST1 Intraosseous Infusion System (2008), 4 descendants of its own

Source page: https://510kreport.com/device/K913258
Methodology: https://510kreport.com/methodology