# K120661: The T.a.L.O.N. Intraossous Infusion System by Vidacre

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Jun 3, 2012 after 90 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915409 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063567: EZ-Mio Sternal, Vidacare Corporation (2007) Summary page 1.
- K970380: F.a.S.T. 1 Intraosseous Infusion System, Pyng Medical Corp. (1997) Summary page 1.

## Recalls of this device
- May 12, 2015 · Class II · Z-1801-2015: Potential breach in sterility

## 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/K120661
Methodology: https://510kreport.com/methodology