Cardiovascular · 510(k) · 2024
APPRAISE-HRI
The Surgeon General, Department of the Army (TSG-DA). Cleared by FDA on 5 April 2024 under submission K233249, product code SAR (adjunctive hemodynamic indicator with decision point for military use). What FDA's record says, in FDA's words.
Device record · K233249
- Device. APPRAISE-HRIDEVICE
- Company. The Surgeon General, Department of the Army (TSG-DA)COMPANY
- Decision. 5 April 2024, 510(k), substantially equivalent (traditional review); received 28 September 2023DECISION
- Panel. CardiovascularPANEL
- Product code. SAR, Adjunctive Hemodynamic Indicator With Decision Point For Military UseCODE
- Regulation. 21 CFR 870.2220, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SAR. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SAR, in Cardiovascular, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.