# K062422: Humeral Head, Manual Driver

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Nov 7, 2006 after 81 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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.
- K052408: EZ-IO, Vidacare Corporation (2005) Summary page 1.

## Indications for use
The Humeral Head, Manual Driver is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.

Source page: https://510kreport.com/device/K062422
Methodology: https://510kreport.com/methodology