# K132583: EZ-IO Intraosseous Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Feb 11, 2014 after 179 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: 7 generations back to K915409 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091140: EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO, Vidacare Corporation (2009) Summary page 1.
- K101026: Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO, Vidacare Corporation (2010) Summary page 1.
- K981853: Bone Injection Gun (B.I.G.) Device, Waismed, Ltd. (1998) Summary page 2.
- K062940: Bone Injection Gun (B.I.G.), Waismed, Ltd. (2006) Summary page 2.
- K915409: Intraosseous Access Needle, Cook, Inc. (1992) Summary page 2.
- K913258: Disposable Introsseous Infusion Needles, Cook, Inc. (1992). Our reading of the summary gave K913256, FDA’s number for Derma-Lase Ruby Laser - Model DLR-1 (Derma-Lase Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cook Intraosseous Infusion Needles”. Summary page 2.

## Indications for use
The EZ-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients 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/K132583
Methodology: https://510kreport.com/methodology