# K060387: Physioflow System

- Pathway: 510(k) (Traditional)
- Applicant: Vasocom, Inc.
- Decided: Apr 10, 2008 after 786 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- 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 K972320 (1997). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041434: C3 and Lifegard Icg Impedance Cardiography Monitors, Analogic Corp. (2004) Summary page 1.

## Most influential descendants
- K103283: Physioflow Enduro (2010), 3 descendants of its own
- K140102: Physioflow Q-Link (2014), 2 descendants of its own
- K172457: Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM (2018), 0 descendants of its own
- K173156: Integrated CardioRespiratory System (2018), 0 descendants of its own

## Indications for use
Indicated for use in adults only The PhysioFlow System noninvasively measures cardiac output and other related cardiac parameters. These parameters include: Cl Cardiac Index CO Cardiac Output CTI Contractility Index dZ / dTmax Maximum value dZ / dT EDV End Diastolic Volume EF Ejection Fraction HR Heart Rate LCWI Left Cardiac Work Index PEP Pre Ejection Period SV Stroke Volume SVR Systemic Vascular Resistance SVRI Systemic Vascular Resistance Index TFI Thoracic Fluid Index VET Ventricular Ejection Time Zo Base Impedance The PhysioFlow System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.

Source page: https://510kreport.com/device/K060387
Methodology: https://510kreport.com/methodology