# K231924: EZ-IO Intraosseous Vascular Access System

- Pathway: 510(k) (Special)
- Applicant: Teleflex Medical
- Decided: Jul 25, 2023 after 25 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 K141117 (2014). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202492: EZ-IO Intraosseous Vascular Access System, Teleflex Medical (2021) Summary page 4.

## Indications for use
For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases up to 24 hours. For patients ≥ 12 years old, the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. INSERTION SITES: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur

Source page: https://510kreport.com/device/K231924
Methodology: https://510kreport.com/methodology