Appraise-HRI
by The Surgeon General, Department of the Army (TSG-DA) 510(k)
Active
510(k) K233249
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233249 | Date5 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- SAR
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2220
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Appraise-HRI is an adjunctive hemodynamic indicator designed for military use, intended to assess hemorrhage risk in trauma patients. Classified as a Class II device under FDA regulation 870.2220, it provides a decision-support tool for evaluating injury severity and stratifying casualties based on physiological data. This software-based solution integrates with mobile health platforms to enhance clinical decision-making in prehospital and field settings.
Supplied as a mobile health application, the Appraise-HRI operates as a single-use digital tool for military healthcare providers. It requires no physical sterilisation but relies on validated algorithms and input parameters to generate hemorrhage risk stratification. The device is intended for use in austere environments, including prehospital and combat settings, and is authorised under FDA 510(k) clearance (K233249). No MRI safety considerations apply, as it is a software-based solution without hardware components.
Other devices from The Surgeon General, Department of the Army (TSG-DA)
Questions
AI-generated answers, 1 Oct 2026
What is the Appraise-HRI designed to do in trauma care?
The Appraise-HRI is a software-based adjunctive hemodynamic indicator intended specifically for military use. It assesses hemorrhage risk in trauma patients by analyzing physiological data to help healthcare providers evaluate injury severity and stratify casualties. This decision-support tool is integrated into mobile health platforms to improve clinical decision-making in austere environments, such as prehospital or combat settings.
How is the Appraise-HRI supplied and used?
The Appraise-HRI is supplied exclusively as a mobile health application, meaning it is a single-use digital tool for military healthcare providers. Unlike physical devices, it does not require sterilization or hardware components. Instead, it relies on validated algorithms and input parameters to generate hemorrhage risk stratification based on patient data entered into the system.
Is the Appraise-HRI reusable or single-use?
The Appraise-HRI is designed as a single-use digital tool within its mobile application environment. Since it operates purely as software, there is no physical component to reuse. Each use case is intended for a specific patient assessment, ensuring data integrity and compliance with military medical protocols.
Does the Appraise-HRI require any special storage conditions?
As a software-based solution, the Appraise-HRI does not require physical storage like traditional medical devices. However, it must be deployed on compatible mobile health platforms that meet military specifications for data security and reliability. The application itself should be maintained in an environment that ensures software integrity, such as updated firmware and secure network access.
Is the Appraise-HRI compatible with MRI environments?
No, the Appraise-HRI does not apply to MRI safety considerations. Since it is a software-based solution without any hardware components, it is not exposed to electromagnetic interference or other MRI-related risks. Its use remains confined to mobile health platforms in prehospital or field settings, where MRI compatibility is irrelevant.