# K140017: Transonic HCM 102 System

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Sep 16, 2014 after 257 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 K023960 (2003). 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)
- K060898: Pulsion Picco Plus, Model 8100, Pulsion Medical Systems AG (2006) Summary page 4.
- K023960: Lidcoplus Hemodynamic Monitor System, Model HM 70, Lidco, Ltd. (2003) Summary page 4.

## Indications for use
The Transonic HCM102 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. This includes COstatus measurements by indicator dilution for quantifying patient’s cardiac and volume status as well as 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 system, cardiac output (CO) value from dilution is used to calibrate the pressure wave form and assess continuous cardiac output. In addition the system also measures heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.

Source page: https://510kreport.com/device/K140017
Methodology: https://510kreport.com/methodology