# K063567: EZ-Mio Sternal

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Jan 26, 2007 after 59 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: 4 generations back to K915409 (1992). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052195: EZ-Mio Manual Driver, Vidacare Corporation (2005) Summary page 1.
- K970380: F.a.S.T. 1 Intraosseous Infusion System, Pyng Medical Corp. (1997) Summary page 1.

## Most influential descendants
- K120661: The T.a.L.O.N. Intraossous Infusion System by Vidacre (2012), 0 descendants of its own

## Indications for use
Sternal IO access is Indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies

Source page: https://510kreport.com/device/K063567
Methodology: https://510kreport.com/methodology