# K052408: EZ-IO

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Nov 17, 2005 after 77 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981853 (1998). 2 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 12 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.

## Most influential descendants
- K062940: Bone Injection Gun (B.I.G.) (2006), 5 descendants of its own
- K142086: Nio -Intraosseous Device (2014), 3 descendants of its own
- K091140: EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO (2009), 2 descendants of its own
- K160805: NIO-P (2016), 1 descendant of its own
- K101026: Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO (2010), 1 descendant of its own

## Recalls of this device
- Mar 31, 2014 · Class II · Z-2672-2014: The voluntary recall is due to the needle set not meeting its specifications.

## Indications for use
The EZ-I0 is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.

Source page: https://510kreport.com/device/K052408
Methodology: https://510kreport.com/methodology