# K063142: Manual PD-IO; Powered PD-IO

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Dec 8, 2006 after 53 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). 7 ancestors in all.
2 later devices descend from it; 1 cites 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 2.
- K051992: Powered PD-IO Intraosseous Infusion System, Vidacare Corporation (2005) Summary page 2.
- K913258: Disposable Introsseous Infusion Needles, Cook, Inc. (1992) Summary page 3.

## 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

## Indications for use
The Manual PD-IO, and Powered PD-1O provide intraosseous access in the distal tibia of pediatric patients as an alternative to IV access during emergencies.

Source page: https://510kreport.com/device/K063142
Methodology: https://510kreport.com/methodology