# K134035: Transonic HCM 103 System

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Sep 17, 2014 after 260 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: 2 generations back to K062134 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082308: Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2008) Summary page 4.
- K010049: Pulseco Hemodynamic Monitor CM71, Lidco, Ltd. (2001) Summary page 4.

## Indications for use
The Transonic HCM103 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. The measurements include continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this stand-alone system, cardiac output (CO) value is entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form for measurement of continuous cardiac output. In addition the system also provides heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.

Source page: https://510kreport.com/device/K134035
Methodology: https://510kreport.com/methodology