Cleared Traditional

K231335 - Cleerly ISCHEMIA (FDA 510(k) Clearance)

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

K231335 · Cleerly, Inc. · Cardiovascular device
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Sep 2023
Decision
123d
Days
Class 2
Risk

K231335 is an FDA 510(k) clearance for the Cleerly ISCHEMIA. Classified as Adjunctive Epicardial Vascular Physiologic Status Indicator (product code QXZ), Class II - Special Controls.

Submitted by Cleerly, Inc. (Denver, US). The FDA issued a Cleared decision on September 8, 2023 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2200 - 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 Cleerly, Inc. devices

Submission Details

510(k) Number K231335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2023
Decision Date September 08, 2023
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QXZ Adjunctive Epicardial Vascular Physiologic Status Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2200
Definition The Adjunctive Epicardial Vascular Physiologic Status Indicator Is A Prescription Device Based On Sensor Technology Or Image Data To Provide Information To An Interpreting Clinician In Detecting The Possible Presence Of Functionally Significant Coronary Artery Disease To Suggest The Need For Further Testing. This Device Is Intended For Adjunctive Use With Other Clinical Workup Or Patient Information And Is Not Intended To Quantify The Degree To Which Epicardial Disease Is Limiting Flow Through A Vessel Nor Is It Intended To Independently Direct Therapy.
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.