# K113821: Transonic Costatus Cardiac Output System

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Sep 7, 2012 after 255 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: 3 generations back to K960817 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080116: Transonic Costatus Cardiac Output System, Transonic Systems, Inc. (2008) Summary page 1.
- K980906: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO, Transonic Systems, Inc. (1998) Summary page 1.
- K023960: Lidcoplus Hemodynamic Monitor System, Model HM 70, Lidco, Ltd. (2003) Summary page 1.

## Most influential descendants
- K134051: Transonic Elsa System (2015), 0 descendants of its own

## Indications for use
The Transonic COstatus system is indicated for use in patients 1 month or older with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

Source page: https://510kreport.com/device/K113821
Methodology: https://510kreport.com/methodology