# K020587: Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046

- Pathway: 510(k) (Traditional)
- Applicant: Pulsion Medical Systems AG
- Decided: May 23, 2002 after 90 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: 2 generations back to K810124 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991886: Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate Sensor, Pulsion Medical Systems, Inc. (2000) Summary page 1.

## 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 burn 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/K020587
Methodology: https://510kreport.com/methodology