Fresenius Blood Volume Monitor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K982926 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Fresenius Medical Care North America →

• What is the Fresenius Blood Volume Monitor used for?

  The Fresenius Blood Volume Monitor is used to monitor blood volume during hemodialysis, providing clinicians with real-time data to assess patient tolerance to ultrafiltration goals and help manage fluid overload in end-stage renal disease patients.

• Is the Fresenius Blood Volume Monitor reusable or single-use?

  The Fresenius Blood Volume Monitor is supplied as a reusable monitor, meaning it is designed for multiple uses in clinical settings such as dialysis centers after appropriate cleaning and maintenance between treatments.

• What regulatory pathway was used for the Fresenius Blood Volume Monitor?

  The Fresenius Blood Volume Monitor received FDA 510(k) clearance under K982926, indicating it was found substantially equivalent to a legally marketed predicate device, and is classified as a Class II medical device.