Cleared Traditional

K233249 - APPRAISE-HRI (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233249 · The Surgeon General, Department of the Army (TSG-DA) · Cardiovascular device
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Apr 2024
Decision
190d
Days
Class 2
Risk

K233249 is an FDA 510(k) clearance for the APPRAISE-HRI. Classified as Adjunctive Hemodynamic Indicator With Decision Point For Military Use (product code SAR), Class II - Special Controls.

Submitted by The Surgeon General, Department of the Army (TSG-DA) (Fort Dietrick, US). The FDA issued a Cleared decision on April 5, 2024 after a review of 190 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2220 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all The Surgeon General, Department of the Army (TSG-DA) devices

Submission Details

510(k) Number K233249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date April 05, 2024
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SAR Adjunctive Hemodynamic Indicator With Decision Point For Military Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2220
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

U.S. Army Medical Materiel Research & Development Command;
Chandar Thakur

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.