# K233249: Appraise-Hri

- Pathway: 510(k) (Traditional)
- Applicant: The Surgeon General, Department of the Army (TSG-DA)
- Decided: Apr 5, 2024 after 190 days
- Product code: SAR (Adjunctive Hemodynamic Indicator With Decision Point For Military Use)
- Device class: 2
- Regulation: 21 CFR 870.2220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200022 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200022: Analytic for Hemodynamic Instability (AHI), Fifth Eye, Inc. (2021) Summary page 5.

## Indications for use
The APPRAISE-HRI is a mobile health app intended to provide a means for military healthcare providers to screen U.S. Service members for hemorrhage risk after a physically traumatic event and stratify casualties who need immediate attention and emergency evacuation from those who are injured but may not be at risk for hemorrhage. The APPRAISE-HRI is not intended to diagnose or direct treatment. Rather, it is intended to provide situational awareness and inform clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk of hemorrhage.

Source page: https://510kreport.com/device/K233249
Methodology: https://510kreport.com/methodology