# K123813: Vascular Positioning System (VPS) G4 Console

- Pathway: 510(k) (Special)
- Applicant: Vasonova, Inc.
- Decided: Jan 18, 2013 after 38 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103260: Vascular Positioning System (VPS System) Console, Vasonova, Inc. (2011) Summary page 1.

## Recalls of this device
- Mar 30, 2015 · Class II · Z-1408-2015: A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.

## Indications for use
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Console is intended for use with the stylet supplied by Vasoova. The Vascular Positioning System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The Vascular Positioning System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. NOTE: If a steady blue bull's eye is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

Source page: https://510kreport.com/device/K123813
Methodology: https://510kreport.com/methodology