# K043490: PD-IO Disposable Intraosseous Infusion Needle

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Feb 18, 2005 after 63 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: 2 generations back to K915409 (1992). 5 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032885: Vidaport Intraosseous Infusion System, Vidacare Corporation (2004) Summary page 1.
- K913258: Disposable Introsseous Infusion Needles, Cook, Inc. (1992) Summary page 1.
- K022415: Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST, Waismed, Ltd. (2002) Summary page 1.

## Most influential descendants
- K052195: EZ-Mio Manual Driver (2005), 13 descendants of its own
- K080865: FAST1 Intraosseous Infusion System (2008), 3 descendants of its own
- K062956: EZ-Mio, EZ-IO Distal Tibia (2006), 3 descendants of its own
- K051992: Powered PD-IO Intraosseous Infusion System (2005), 3 descendants of its own
- K100124: Fastx Sternal Intraosseous Device (2010), 2 descendants of its own

## Indications for use
The PD-10 Disposable Intraosseous Infusion Needle and Handle provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients.

Source page: https://510kreport.com/device/K043490
Methodology: https://510kreport.com/methodology