Cleared Special

K263380 - STAR Apollo™ Mapping System

K263380 is an FDA 510(k) clearance for STAR Apollo Mapping System, manufactured by Rhythm AI, Ltd.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 29-day FDA review.

K263380 · Rhythm AI, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
29d
Days
Class 2
Risk

K263380 is an FDA 510(k) clearance for the STAR Apollo™ Mapping System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Rhythm AI, Ltd. (London, GB). The FDA issued a Cleared decision on October 23, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 - K263380

510(k) Number K263380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2026
Decision Date October 23, 2026
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 Peers - DQK Computer, Diagnostic, Programmable

All 437
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K263380.
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K262005 · Medtronic, Inc. · Aug 2026
K263380 · STAR Apollo™ Mapping System
Download PDF FDA Summary Rhythm AI, Ltd.