# K191976: Piper GO-IO Intraosseous Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Piper Access, LLC
- Decided: Nov 13, 2019 after 112 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 2 (2 Class I)
- 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.
2 later devices descend from it; 1 cites it directly.
2 of 4 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
- K203193: BD Intraosseous Infusion System (2021), 1 descendant of its own
- K223198: BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (2022), 0 descendants of its own

## Recalls of this device
- Jul 30, 2026 · Class I · Z-2872-2026: After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/i
- Jun 20, 2022 · Class I · Z-1397-2022: BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraoss

## Indications for use
The Piper GO-IO® Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult 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/K191976
Methodology: https://510kreport.com/methodology