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Thermal Diffusion Cerebral Blood Flow Monitor

by Flowtronics, Inc.

510(k) K850657

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 NumberK850657 Date22 Feb 1985ClearedStatusActive

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  • Withdrawn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
LME
Device Class
Class III
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Thermal Diffusion Cerebral Blood Flow Monitor is a Class III medical device designed for continuous, non-invasive measurement of cerebral blood flow (CBF) using thermal diffusion technology. It employs a transducer-tipped sensor to detect blood flow dynamics in the cortical bed, providing real-time monitoring of perfusion parameters without requiring invasive procedures.

This device is intended for use in clinical settings such as neurointensive care units or neurosurgical environments, where precise CBF assessment is critical. Supplied as a reusable system with associated sensors, cables, and accessories, it adheres to FDA 510(k) clearance (K850657) under product code LME. No specific sterility or MRI safety information is provided in the regulatory data.

Questions

AI-generated answers, 18 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 clinical environments is the Thermal Diffusion Cerebral Blood Flow Monitor primarily used in, and why is it beneficial there?

    The Thermal Diffusion Cerebral Blood Flow Monitor is designed for neurointensive care units and neurosurgical environments, where real-time monitoring of cerebral blood flow (CBF) is critical. Its non-invasive approach avoids the risks and complications of invasive procedures, allowing continuous assessment of perfusion dynamics in patients with conditions like stroke, traumatic brain injury, or post-surgical monitoring where precise CBF data is essential for clinical decision-making.

  • Is the Thermal Diffusion Cerebral Blood Flow Monitor a single-use or reusable device, and what does this mean for maintenance?

    The device is supplied as a reusable system, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. This design allows for cost efficiency in clinical settings but requires adherence to manufacturer guidelines for sterilization and upkeep to ensure accuracy and safety between uses.

  • What components are included in the supplied Thermal Diffusion Cerebral Blood Flow Monitor system, and how does it function?

    The system includes a reusable monitor unit, transducer-tipped sensors, cables, and associated accessories. It functions by placing the sensor on the patient’s scalp to detect blood flow dynamics in the cortical bed using thermal diffusion technology, enabling continuous, non-invasive measurement of cerebral perfusion parameters in real time.

  • Does the Thermal Diffusion Cerebral Blood Flow Monitor require any special storage conditions, and if so, what are they?

    The regulatory data does not specify any special storage conditions for the Thermal Diffusion Cerebral Blood Flow Monitor. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality and ensure longevity between uses.