510(k) · Cleared
ClearedAppraise-Hri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Surgeon General, Department of the Army (TSG-DA) · SAR Adjunctive Hemodynamic Indicator With Decision Point For Military Use
Cleared on Apr 5, 2024 as substantially equivalent to DEN200022 (Fifth Eye, Inc., 2021) after a 190-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Apr 5, 2024
- Review
- 190 days
- Class
- Class II
- Product code
- SAR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200022 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200022 Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc. · 2021
- This deviceK233249 Appraise-HriThe Surgeon General, Department of the Army (TSG-DA) · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200022 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye, Inc. | 2021 | — |
| 0 (this device) | K233249 | Appraise-Hri | The Surgeon General, Department of the Army (TSG-DA) | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SAR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200022 | Analytic for Hemodynamic Instability (AHI)Summary page 5…Point Product Code: SAR Predicate Device Details Device Trade Name: Analytic for Hemodynamic Instability (AHI) De Novo number: DEN200022 Common Name: Adjunctive Hemodynamic Indicator with Decision Point Classification: Class II Classificatio… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN200022.
How does its category compare?
All SAR devicesSAR Adjunctive Hemodynamic Indicator With Decision Point For Military Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SAR
Too few SAR 510(k)s in any year since 2007 to give a median.
Recalls per year · SAR
No recall names SAR since 2007.
Adverse event reports per year · SAR
No MAUDE report names SAR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233249: Appraise-Hri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233249
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026