# K203193: BD Intraosseous Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd]
- Decided: Mar 4, 2021 after 127 days
- Product code: MHC (Needle, Interosseous)
- 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: 2 generations back to K141117 (2014). 2 ancestors in all.
1 later device descends 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)
- K191976: Piper GO-IO Intraosseous Infusion System, Piper Access, LLC (2019) Summary page 4.

## Most influential descendants
- 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 BD Inttaosseous 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/K203193
Methodology: https://510kreport.com/methodology