# K191488: SAM IO Intraosseous Access System

- Pathway: 510(k) (Traditional)
- Applicant: Sam® Medical Products, Inc.
- Decided: Nov 21, 2019 after 170 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K240915: ZIEN IO Intraosseous Access System (2024), 0 descendants of its own

## Indications for use
The SAM 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/K191488
Methodology: https://510kreport.com/methodology