# K103283: Physioflow Enduro

- Pathway: 510(k) (Special)
- Applicant: Vasocom, Inc.
- Decided: Dec 3, 2010 after 28 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: 4 generations back to K972320 (1997). 6 ancestors in all.
3 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)
- K060387: Physioflow System, Vasocom, Inc. (2008) Summary page 1.

## Most influential descendants
- 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 Enduro PF07 noninvasively measures cardiac output and other related cardiac parameters. These parameters include: CI Cardiac Index CO Cardiac Output CTI Contractility Index dZ / dt max 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 Enduro System Model PF-07 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/K103283
Methodology: https://510kreport.com/methodology