# K022415: Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST

- Pathway: 510(k) (Traditional)
- Applicant: Waismed, Ltd.
- Decided: Oct 11, 2002 after 79 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 K915409 (1992). 3 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981853: Bone Injection Gun (B.I.G.) Device, Waismed, Ltd. (1998) Summary page 1.
- K915409: Intraosseous Access Needle, Cook, Inc. (1992) Summary page 1.
- K913258: Disposable Introsseous Infusion Needles, Cook, Inc. (1992) Summary page 1.

## Most influential descendants
- K043490: PD-IO Disposable Intraosseous Infusion Needle (2005), 16 descendants of its own
- K052195: EZ-Mio Manual Driver (2005), 13 descendants of its own
- K080865: FAST1 Intraosseous Infusion System (2008), 3 descendants of its own
- K062956: EZ-Mio, EZ-IO Distal Tibia (2006), 3 descendants of its own
- K051992: Powered PD-IO Intraosseous Infusion System (2005), 3 descendants of its own

## Indications for use
The B.I.Gm- Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age,

Source page: https://510kreport.com/device/K022415
Methodology: https://510kreport.com/methodology