# K081626: Flowpicc Console

- Pathway: 510(k) (Traditional)
- Applicant: Vasonova, Inc.
- Decided: Oct 15, 2008 after 127 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.
39 later devices descend from it; 2 cite it directly.
6 of 66 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 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 a 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 information.

Source page: https://510kreport.com/device/K081626
Methodology: https://510kreport.com/methodology