# K081625: Flowpicc Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Vasonova, Inc.
- Decided: Sep 26, 2008 after 108 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001901 (2000). 26 ancestors in all.
40 later devices descend from it; 3 cite it directly.
6 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041134: Combomap Pressure and Flow System, Volcano Therapeutics, Inc. (2004) Summary page 1.
- K063240: Sherlock TLS Stylet, Sherlock TLS Detector, C.R. Bard, Inc. (2006) Summary page 1.

## Most influential descendants
- K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet (2009), 38 descendants of its own
- K093775: Evguide Tip Location System (2010), 34 descendants of its own
- K140799: Celerity Sysyem (2014), 13 descendants of its own
- K103255: Vascular Positioning System TM (VPS TM System) Stylet (2011), 10 descendants of its own
- K142889: Celerity PICC Tip Confirmation System (2015), 8 descendants of its own

## Indications for use
The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021" for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording, and intravascular ultrasound for catheter guiding and positioning.

Source page: https://510kreport.com/device/K081625
Methodology: https://510kreport.com/methodology