# K083384: Thermodilution Catheter

- Pathway: 510(k) (Special)
- Applicant: Biosensors Intl. Pte., Ltd.
- Decided: Jan 5, 2010 after 414 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- 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: 1 generation back to K911710 (1991). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911710: Heparin Coated Thermodilution Cath & Accessories, Sunscope Intl., Inc. (1991) Summary page 1.

## Most influential descendants
- K094048: Percupro Messenger Balloon Catheter (2011), 0 descendants of its own
- K101669: Thermodilution Catheter (2010), 0 descendants of its own

## Indications for use
Biosensors flow-directed Thermodilution catheters are designed for use in critical care patients to measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computers which interface with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients. The tips of the catheters are mounted with a latex balloon which when inflated, protects the heart tissues from the product’s tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.

Source page: https://510kreport.com/device/K083384
Methodology: https://510kreport.com/methodology