# K223198: BD Intraosseous Vascular Access System EMS Powered Driver (D001003)

- Pathway: 510(k) (Special)
- Applicant: Bard Access Systems
- Decided: Nov 10, 2022 after 28 days
- Product code: MHC (Needle, Interosseous)
- 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: 3 generations back to K141117 (2014). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203193: BD Intraosseous Infusion System, Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] (2021) Summary page 5.

## Indications for use
The BD Intraosseous Vascular Access 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/K223198
Methodology: https://510kreport.com/methodology