Cleared Special

K262839 - Cleerly ISCHEMIA

K262839 is an FDA 510(k) clearance for Cleerly ISCHEMIA, manufactured by Cleerly, Inc.. The device is a Class 2 Cardiovascular device with product code QXZ cleared through the Special 510(k) pathway after a 79-day FDA review.

K262839 · Cleerly, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
79d
Days
Class 2
Risk

K262839 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 October 29, 2026 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262839

510(k) Number K262839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2026
Decision Date October 29, 2026
Days to Decision 79 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

QXZ Device Classification - Class 2, Special Controls

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.

K262839 · Cleerly ISCHEMIA
Download PDF FDA Summary Cleerly, Inc.