BProSOFT CASP PC Software

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

510(k) Number

K131916 ↗

FDA Product Code

DXN

FDA applicant

Healthstats International Pte. , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• A-Plus Arterial Pulse Waveform Analysis System and Pc Software

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  FDA 510(k) K072593 Active Cleared 15 Nov 2007

• What specific type of blood pressure data does the BProSOFT CASP software analyze, and how does it differ from standard blood pressure monitoring tools?

  The BProSOFT CASP software analyzes arterial pulse waveforms from ambulatory blood pressure monitoring systems, going beyond standard tools by calculating central aortic systolic pressure (CASP). While traditional monitors measure brachial blood pressure, this software provides additional cardiovascular insights—like aortic pressure—which can help assess hypertension and cardiovascular risk more comprehensively.

• Is this software compatible with any specific ambulatory blood pressure devices, or does it require particular hardware to function?

  The BProSOFT CASP software is designed to work only with compatible ambulatory blood pressure monitoring devices, though the exact models aren’t listed in the data. It functions as a standalone analytical tool, meaning it relies on data exported from those devices rather than operating as a standalone monitor itself. Always verify compatibility with your existing equipment before use.

• Since this is a digital product, how is it supplied, and do I need to worry about sterility or single-use considerations?

  The software is supplied digitally—no physical hardware or consumables are involved. Because it’s a computer program, there are no sterility or single-use requirements like with medical devices that contact patients. It’s intended for use on a PC, so no additional handling precautions apply beyond standard IT security and software installation guidelines.

• What regulatory pathway was followed for this software, and which advisory committee was involved in its review?

  The BProSOFT CASP software underwent a traditional FDA 510(k) review under the Cardiovascular (CV) advisory committee, with a decision code of SESE (Substantially Equivalent). This means it was deemed comparable to a legally marketed device in terms of technology and performance, ensuring its safety and effectiveness for calculating central aortic systolic pressure in clinical settings.