# K091140: EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Oct 14, 2009 after 177 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). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062956: EZ-Mio, EZ-IO Distal Tibia, Vidacare Corporation (2006) Summary page 1.
- K032885: Vidaport Intraosseous Infusion System, Vidacare Corporation (2004) Summary page 1.
- K052408: EZ-IO, Vidacare Corporation (2005) Summary page 1.

## Most influential descendants
- K101026: Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO (2010), 1 descendant of its own
- K132583: EZ-IO Intraosseous Infusion System (2014), 0 descendants of its own

## Recalls of this device
- Mar 29, 2017 · Class III · Z-1829-2017: Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

## Indications for use
EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only. EZ-IO Humeral Head: The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

Source page: https://510kreport.com/device/K091140
Methodology: https://510kreport.com/methodology