APPRAISE-HRI

K233249

The Surgeon General, Department of the Army (TSG-DA) · cleared 2024-04-05 · product code SAR · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“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.”
Algorithmartificial intelligence (AI) linear regression model
source quote (p.6)
“The APPRAISE-HRI algorithm, which provides the core functionality to this device, consists of three modules. The first module pre-processes the raw vital-sign data and provides minute-by-minute values as valid input for the second module, an artificial intelligence (AI) linear regression model.”
Adaptive (vs locked)No
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: software specifications met

standards: ISO 14971:2019, IEC 62304 2016

Retrospective clinical

n=5,895 patients · 9 site(s)

endpoints: Likelihood Ratios for HRI Levels I, II, and III for the first HRI output of each patient; other statistical metrics; analysis of different subgroups of interest [age, mode of injury (blunt vs. penetrating), and clinical study site]; analysis through time

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K233249