# K072364: Pulsion Pulsiocath Thermodilution Catheters & Accessories

- Pathway: 510(k) (Special)
- Applicant: Pulsion Medical Systems AG
- Decided: Sep 19, 2007 after 28 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
No predicates in its family tree.
4 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100739: Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5 (2010), 2 descendants of its own
- K110167: Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin) (2011), 1 descendant of its own
- K171620: PiCCO Catheter (2018), 0 descendants 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 Pulsion Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac, and bum specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

Source page: https://510kreport.com/device/K072364
Methodology: https://510kreport.com/methodology