# K101026: Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Jul 27, 2010 after 105 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: 6 generations back to K915409 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051992: Powered PD-IO Intraosseous Infusion System, Vidacare Corporation (2005) Summary page 1.
- K052408: EZ-IO, Vidacare Corporation (2005) Summary page 1.
- K063142: Manual PD-IO; Powered PD-IO, Vidacare Corporation (2006) Summary page 1.
- K091140: EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO, Vidacare Corporation (2009) Summary page 1.

## Most influential descendants
- K132583: EZ-IO Intraosseous Infusion System (2014), 0 descendants of its own

## Indications for use
The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The Humeral Head EZ-l0 provides vascular access when standard venous access is not possible. Humeral head 10 access is indicated in pediatrics in e~rergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24 hours. The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours.The device is for use in pediatric patients (approximate weight range: 3kg-39kg).

Source page: https://510kreport.com/device/K101026
Methodology: https://510kreport.com/methodology