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QFlow 500 Perfusion Monitoring System

by Hemedex Incorporated

510(k) K013376

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013376 Date8 May 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPW
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The QFlow 500 Perfusion Monitoring System is a device that continuously quantifies tissue perfusion in absolute physiological units of ml/100g-min in real time using a thermal diffusion technique. It consists of a thermal diffusion probe and a monitor, with the probe containing two thermistors at its distal tip that is inserted into tissue to measure thermal conductivity and real-time perfusion via thermal energy dissipation.

The system is supplied as part of a monitoring setup and is authorized under FDA 510K clearance. It is designed for use in cardiovascular applications and is classified as a Class 2 device. The system includes various model numbers and is regulated under product code DPW with regulation number 870.2100.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the QFlow 500 Perfusion Monitoring System used for?

    The QFlow 500 is a device that continuously quantifies tissue perfusion in absolute physiological units of ml/100g-min in real time using a thermal diffusion technique. It is designed for cardiovascular applications and consists of a thermal diffusion probe and a monitor.

  • How is the QFlow 500 Perfusion Monitoring System supplied?

    The system is supplied as part of a monitoring setup that includes a thermal diffusion probe and a monitor. The probe contains two thermistors at its distal tip that is inserted into tissue to measure thermal conductivity and real-time perfusion via thermal energy dissipation.

  • What is the regulatory classification of the QFlow 500 Perfusion Monitoring System?

    The QFlow 500 is classified as a Class 2 device and is authorized under FDA 510K clearance. It is regulated under product code DPW with regulation number 870.2100. The system was found to be substantially equivalent to other devices in its class.

  • What models are available for the QFlow 500 Perfusion Monitoring System?

    The QFlow 500 Perfusion Monitoring System includes various model numbers, though specific model details are not provided in the available data. The system is designed to provide real-time tissue perfusion measurements using a thermal diffusion technique.