# K180395: EZ-IO Intraosseous Vascular Access System

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Decided: Nov 9, 2018 after 269 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: 1 generation back to K141117 (2014). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141117: EZ-IO Intraosseous Infusion System, Vidacare, LLC (2014) Summary page 4.

## Most influential descendants
- K202492: EZ-IO Intraosseous Vascular Access System (2021), 1 descendant of its own
- K231924: EZ-IO Intraosseous Vascular Access System (2023), 0 descendants of its own
- K220890: IO Needle Safety Sheath (2022), 0 descendants of its own

## Indications for use
For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur Use of 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): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur

Source page: https://510kreport.com/device/K180395
Methodology: https://510kreport.com/methodology