# K120349: Sonixgps Vascular Access Needle Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasonix Medical Corpation
- Decided: Apr 9, 2012 after 63 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K891022 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081940: Avalon Elite Vascular Access Kit, Avalon Laboratories, LLC (2008) Summary page 1.

## Indications for use
The device is intended for use by a trained physician in conjunction with the SonixGPS Needle Sensor to assist in vessel cannulation.

Source page: https://510kreport.com/device/K120349
Methodology: https://510kreport.com/methodology