# K062940: Bone Injection Gun (B.I.G.)

- Pathway: 510(k) (Traditional)
- Applicant: Waismed, Ltd.
- Decided: Dec 22, 2006 after 85 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: 3 generations back to K981853 (1998). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 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.
- K052408: EZ-IO, Vidacare Corporation (2005) Summary page 1.

## Most influential descendants
- K142086: Nio -Intraosseous Device (2014), 3 descendants of its own
- K160805: NIO-P (2016), 1 descendant of its own
- K211968: NIO+ Adult (2021), 0 descendants of its own
- K191258: Intraosseous infusion device (2019), 0 descendants of its own
- K132583: EZ-IO Intraosseous Infusion System (2014), 0 descendants of its own

## Indications for use
The Bone Injection Gun (BIG) is intended to provide intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.

Source page: https://510kreport.com/device/K062940
Methodology: https://510kreport.com/methodology