Quantix/OR Blood Flow Monitor; Flexible Probe With Optional Vessel Stabilizer

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

510(k) Number

K050088 ↗

FDA Product Code

DPW

Models / Variants

Quantix/Or Blood Flow Monitor

Flexible Probe With Optional Vessel Stabilizer

Device Class

Class II

Regulation

21 CFR Part 870.2100

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Quantix/OR Blood Flow Monitor used for?

  The Quantix/OR Blood Flow Monitor is designed to measure blood flow velocity through vessels using angle-independent, pulse-wave Doppler ultrasound technology. This allows for both invasive and noninvasive diagnostic evaluations of vascular hemodynamics, helping clinicians assess blood flow dynamics in cardiovascular applications.

• Is the Quantix/OR Blood Flow Monitor reusable or single-use?

  The Quantix/OR Blood Flow Monitor is supplied as a reusable system. It includes a flexible probe and an optional vessel stabilizer, both intended for repeated use under proper maintenance and cleaning protocols as specified by the manufacturer.

• Does the Quantix/OR Blood Flow Monitor include any accessories for improved accuracy?

  Yes, the device is available with an optional vessel stabilizer. This accessory is designed to enhance measurement accuracy by improving probe positioning and reducing motion artifacts during blood flow assessments.

• What storage conditions are required for the Quantix/OR Blood Flow Monitor?

  The Quantix/OR Blood Flow Monitor requires appropriate storage conditions as outlined by the manufacturer. While the device itself is not MRI-safe, proper handling, cleaning, and environmental controls (e.g., temperature, humidity) are essential to maintain performance and sterility when reused.

• What regulatory pathway does the Quantix/OR Blood Flow Monitor follow?

  The Quantix/OR Blood Flow Monitor is authorized under FDA 510(k) clearance (K050088) and falls under Class II (Special) regulatory classification (Regulation Number: 870.2100). This classification indicates it is subject to special controls for cardiovascular devices, ensuring compliance with stringent safety and performance standards.