# K240915: ZIEN IO Intraosseous Access System

- Pathway: 510(k) (Traditional)
- Applicant: Zien Medical Technologies, Inc.
- Decided: Jul 2, 2024 after 90 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 K141117 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191488: SAM IO Intraosseous Access System, Sam® Medical Products, Inc. (2019) Summary page 4.

## Indications for use
The ZIEN IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in 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/K240915
Methodology: https://510kreport.com/methodology