# K103255: Vascular Positioning System TM (VPS TM System) Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Vasonova, Inc.
- Decided: Feb 18, 2011 after 107 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 32 ancestors in all.
10 later devices descend from it; 5 cite it directly.
5 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081625: Flowpicc Stylet, Vasonova, Inc. (2008) Summary page 1.
- K093775: Evguide Tip Location System, Romedex International Srl (2010) Summary page 1.

## Most influential descendants
- K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet (2013), 3 descendants of its own
- K123759: CG+ Arrow Picc Powered by Arrow VPS Stylet (2013), 3 descendants of its own
- K130876: CG+ Arrow Picc Powered by Arrow VPS Stylet (2013), 2 descendants of its own
- K122545: CG+ Arrow Picc Powered by Arrow VPS Stylet (2012), 2 descendants of its own
- K153423: CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (2016), 1 descendant of its own

## Recalls of this device
- Jun 1, 2017 · Class II · Z-0179-2018: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
- Apr 28, 2017 · Class II · Z-2170-2017: Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Secu
- Jul 30, 2015 · Class II · Z-2462-2015: the catheter peel-away component hub tabs may prematurely detach. One injury reported.
- Jul 30, 2015 · Class II · Z-2489-2015: saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.

## Indications for use
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for EG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical. activity and blood flow) information. When the VPS System guidance indicator shows a blue bullseye, the catheter tip is in the desired location. The VPS 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. 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/K103255
Methodology: https://510kreport.com/methodology