# K991886: Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Pulsion Medical Systems, Inc.
- Decided: May 11, 2000 after 344 days
- Product code: KRB (Probe, Thermodilution)
- Device class: 2
- Regulation: 21 CFR 870.1915
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810124 (1981). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810124: Swan-Ganz Vip Thermodilution Catheter, American Edwards Laboratories (1981) Summary page 1.
- K810675: Arrow Radial Artery Catheterization Set, Arrow Intl., Inc. (1981) Summary page 1.
- K892941: Cco System Model SP1467,SP5567,SP6267, Spectramed, Inc. (1989) Summary page 1.
- K842352: Pressure Monitoring Kit, Utah Medical Products, Inc. (1985) Summary page 1.
- K841788: Utah Disposable Pressure Transducer, Utah Medical Products, Inc. (1985) Summary page 1.

## Most influential descendants
- K020587: Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046 (2002), 0 descendants of its own

## Recalls of this device
- Nov 4, 2014 · Class II · Z-1121-2015: Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

## 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/K991886
Methodology: https://510kreport.com/methodology