# K051992: Powered PD-IO Intraosseous Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Oct 20, 2005 after 90 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: 3 generations back to K915409 (1992). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043490: PD-IO Disposable Intraosseous Infusion Needle, Vidacare Corporation (2005) Summary page 1.
- K032885: Vidaport Intraosseous Infusion System, Vidacare Corporation (2004) Summary page 1.

## Most influential descendants
- K063142: Manual PD-IO; Powered PD-IO (2006), 2 descendants of its own
- 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

## Indications for use
The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg).

Source page: https://510kreport.com/device/K051992
Methodology: https://510kreport.com/methodology