Cleared Traditional

K241227 - RHYTHMIA HDx Mapping System

K241227 is the FDA 510(k) clearance for RHYTHMIA HDx Mapping System by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 246
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
Affera Integrated Mapping System
K241828 · Medtronic, Inc. · Nov 2024
Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)
K242133 · Centerline Biomedical, Inc. · Oct 2024
HeartKey® Rhythm
K233755 · B-Secur Limited · Aug 2024
EnSite™ X EP System
K242016 · Abbott Medical · Aug 2024
STAR Apollo™ Mapping System
K240509 · Rhythm AI, Ltd. · Jul 2024