# K080116: Transonic Costatus Cardiac Output System

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Sep 8, 2008 after 236 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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: 2 generations back to K960817 (1997). 3 ancestors in all.
2 later devices descend 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)
- K023960: Lidcoplus Hemodynamic Monitor System, Model HM 70, Lidco, Ltd. (2003) Summary page 1.
- K980906: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO, Transonic Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K113821: Transonic Costatus Cardiac Output System (2012), 1 descendant of its own
- K134051: Transonic Elsa System (2015), 0 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1147-2013: Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

## Indications for use
The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) 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/K080116
Methodology: https://510kreport.com/methodology