Biodynamics Autotransfusion Reservoir

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

510(k) Number

K881631 ↗

FDA Product Code

CAC

Device Class

Class II

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Biodynamics Corp. →

• What is the Biodynamics Autotransfusion Reservoir used for?

  The Biodynamics Autotransfusion Reservoir is designed for autotransfusion, which is the process of collecting and reinfusing a patient's own blood that would otherwise be lost during surgical procedures.

• Is the Biodynamics Autotransfusion Reservoir single-use or reusable?

  The device data does not specify whether the Biodynamics Autotransfusion Reservoir is single-use or reusable. This information should be confirmed with the manufacturer directly.

• What is the regulatory status of the Biodynamics Autotransfusion Reservoir?

  The Biodynamics Autotransfusion Reservoir is FDA 510(k) cleared with K number K881631, classified as a Class II medical device under product code CAC, and regulated under 21 CFR 868.5830.

• In what settings is the Biodynamics Autotransfusion Reservoir intended to be used?

  The Biodynamics Autotransfusion Reservoir is intended for use in anesthesiology settings during surgical procedures where blood collection and reinfusion may be beneficial.