# K100739: Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 7, 2010 after 266 days
- Product code: KRB (Probe, Thermodilution)
- Device class: 2
- Regulation: 21 CFR 870.1915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935170 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072364: Pulsion Pulsiocath Thermodilution Catheters & Accessories, Pulsion Medical Systems AG (2007) Summary page 1.
- K935170: Cardiovascular and Vascular Guidewire Modifications, Lake Region Mfg., Inc. (1994) Summary page 1.

## Most influential descendants
- K110167: Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin) (2011), 1 descendant of its own
- K113565: Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central Venous Catheters (CVCS), with Heparin (2012), 0 descendants of its own

## Indications for use
The VolumeView system is indicated for use in critical care patients in which cardio-respiratory function, fluid status, and vascular resistance need constant and/or intermittent assessment. The femoral arterial catheter is indicated for femoral artery insertion.

Source page: https://510kreport.com/device/K100739
Methodology: https://510kreport.com/methodology