# K962918: Lidco System

- Pathway: 510(k) (Traditional)
- Applicant: Lidco, Ltd.
- Decided: Jan 8, 1999 after 925 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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 K760192 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810352: Swan-Ganz Flow-Directed Thermodilution, American Edwards Laboratories (1981) Summary page 2.
- K760192: Computer, Thermodilution Cardiac (9520), Edwards Laboratories (1976) Summary page 5.

## Indications for use
Diagnostic aid (cardiac output determination). The LIDCO System is intended for the monitoring of cardiac output (blood flow in litres per minute) in patients of greater than 88 lbs (40 kg) in weight.

Source page: https://510kreport.com/device/K962918
Methodology: https://510kreport.com/methodology