Cleared Traditional

K241227 - RHYTHMIA HDx™ Mapping System

K241227 is an FDA 510(k) clearance for RHYTHMIA HDx Mapping System, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K241227 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
119d
Days
Class 2
Risk

K241227 is an FDA 510(k) clearance for the RHYTHMIA HDx™ Mapping System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Boston Scientific Corporation (St Paul, US). The FDA issued a Cleared decision on August 29, 2024 after a review of 119 days - within the typical 510(k) review window.

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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K241227

510(k) Number K241227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2024
Decision Date August 29, 2024
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 360
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K241227.
DeepRhythmAI
K241197 · Medicalgorithmics S.A. · Dec 2024
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K241828 · Medtronic, Inc. · Nov 2024
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K242133 · Centerline Biomedical, Inc. · Oct 2024
HeartKey® Rhythm
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K242016 · Abbott Medical · Aug 2024
STAR Apollo™ Mapping System
K240509 · Rhythm AI, Ltd. · Jul 2024