# K981853: Bone Injection Gun (B.I.G.) Device

- Pathway: 510(k) (Traditional)
- Applicant: Waismed, Ltd.
- Decided: Nov 17, 1998 after 175 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.
40 later devices descend from it; 5 cite it directly.
0 of 41 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
- K032885: Vidaport Intraosseous Infusion System (2004), 38 descendants of its own
- 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
- K062833: Powered EZ-IO Bone Marrow Aspiration System (2006), 14 descendants of its own
- K052195: EZ-Mio Manual Driver (2005), 13 descendants of its own

## Indications for use
The Bone Injection Gun (B.1.G.) is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

Source page: https://510kreport.com/device/K981853
Methodology: https://510kreport.com/methodology