Hematocrit-Saturation Monitor HSM-100

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

510(k) Number

K852124 ↗

FDA Product Code

DRY

Device Class

Class II

Regulation

21 CFR Part 870.4330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bentley →

• What is the HSM-100 used for?

  The HSM-100 is a blood-gas monitoring device used during cardiopulmonary bypass procedures. It provides continuous measurement of hematocrit and oxygen saturation levels in the extracorporeal circuit to support clinical decision-making in cardiovascular surgical settings.

• How is the HSM-100 supplied?

  The HSM-100 is manufactured by American Bentley and supplied as a Class II medical device. It is intended for online use during surgery and is designed to integrate with the extracorporeal circuit for real-time monitoring.

• Is the HSM-100 single-use or reusable?

  The device data does not specify whether the HSM-100 is single-use or reusable. However, as an online monitor used during cardiopulmonary bypass, it is likely a reusable electronic system that requires sterilization and maintenance between procedures, consistent with similar surgical monitoring equipment.

• What sizes and models are available?

  The device data lists only one model: the HEMATOCRIT-SATURATION MONITOR HSM-100. No additional sizes or variants are mentioned, suggesting it is offered as a single configuration for its intended use in cardiac surgery.

• How should the HSM-100 be stored?

  Storage conditions for the HSM-100 are not detailed in the provided data. As a Class II electronic medical device, it should be stored in a dry, temperature-controlled environment away from moisture and extreme conditions, following the manufacturer’s instructions for handling and preservation.