Cleared Traditional

K162793 - RHYTHMIA HDx Mapping System

K162793 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 157-day FDA review.

K162793 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
157d
Days
Class 2
Risk

K162793 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 (Cambridge, US). The FDA issued a Cleared decision on March 10, 2017 after a review of 157 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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K162793

510(k) Number K162793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2016
Decision Date March 10, 2017
Days to Decision 157 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
32d slower than avg
Panel avg: 125d · This submission: 157d
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 363
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K162793.
CARTO 3 EP Navigation System, Version 6.0 and Accessories
K170600 · Biosense Webster, Inc. · Jul 2017
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
K163381 · Edwards Lifesciences, LLC · Apr 2017
CardioDay V2.5
K162023 · Getemed Medizin- Und Informationstechnik AG · Mar 2017
EnSite Precision Cardiac Mapping System v2.0
K160210 · St Jude Medical · Dec 2016
AutoMark Module
K160218 · St Jude Medical · Dec 2016
MediGuide Technology System
K162643 · St Jude Medical · Dec 2016