Cleared Traditional

K250635 - FEops HEARTguide Simulation Application (FDA 510(k) Clearance)

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

K250635 · Feops NV · Cardiovascular device
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Nov 2025
Decision
267d
Days
Class 2
Risk

K250635 is an FDA 510(k) clearance for the FEops HEARTguide Simulation Application. Classified as Interventional Cardiovascular Implant Simulation Software Device (product code QQI), Class II - Special Controls.

Submitted by Feops NV (Gent, BE). The FDA issued a Cleared decision on November 25, 2025 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1405 - 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.

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Submission Details

510(k) Number K250635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2025
Decision Date November 25, 2025
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QQI Interventional Cardiovascular Implant Simulation Software Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1405
Definition An Interventional Cardiovascular Implant Simulation Software Device Is A Prescription Device That Provides A Computer Simulation Of An Interventional Cardiovascular Implant Device Inside A Patient’s Cardiovascular Anatomy. It Performs Computational Modeling To Predict The Interaction Of The Interventional Cardiovascular Implant Device With The Patient-specific Anatomical Environment.
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.