Cleared Traditional

STAR Apollo™ Mapping System (K240509) - FDA 510(k) Clearance

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

K240509 · Rhythm AI, Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2024
Decision
155d
Days
Class 2
Risk

K240509 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 July 26, 2024 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Rhythm AI, Ltd. devices

Submission Details

510(k) Number K240509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2024
Decision Date July 26, 2024
Days to Decision 155 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
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
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