Cleared Traditional

K192438 - Rhythmia HDxTM Mapping System

K192438 is the FDA 510(k) clearance for Rhythmia HDxTM 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 82-day FDA review.

K192438 · Boston Scientific Corporation · Cardiovascular device
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Nov 2019
Decision
82d
Days
Class 2
Risk

K192438 is an FDA 510(k) clearance for the Rhythmia HDxTM 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 November 27, 2019 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K192438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2019
Decision Date November 27, 2019
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
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 251
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K192438.
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