510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233249Substantially Equivalent

Appraise-Hri

The Surgeon General, Department of the Army (TSG-DA), Fort Dietrick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233249 is the FDA 510(k) clearance record for APPRAISE-HRI, a class II device, cleared for The Surgeon General, Department of the Army (TSG-DA) on under FDA product code SAR (Adjunctive Hemodynamic Indicator With Decision Point For Military Use). FDA's definition for product code SAR reads: "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...". FDA records list 2 510(k) clearances for The Surgeon General, Department of the Army (TSG-DA), from to . As of , FDA records show no recalls naming K233249.

Clearance record

Decision date
Received
(190 days to decision)
Product code
SAR Adjunctive Hemodynamic Indicator With Decision Point For Military Use
Regulation
21 CFR 870.2220
Device class
Class II
Review panel
Cardiovascular
Applicant
The Surgeon General, Department of the Army (TSG-DA) U.S. Army Medical Materiel Research & Development Command;, Fort Dietrick MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAR

Trailing 12 months

FDA records hold no clearances under product code SAR in the trailing twelve months.

FDA records show no clearances under product code SAR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SAR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260