Cleared Traditional

K181918 - CardioInsight Cardiac Mapping System

K181918 is the FDA 510(k) clearance for CardioInsight Cardiac Mapping System by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K181918 · Medtronic, Inc. · Cardiovascular device
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Nov 2018
Decision
113d
Days
Class 2
Risk

K181918 is an FDA 510(k) clearance for the CardioInsight Cardiac Mapping System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on November 8, 2018 after a review of 113 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 Medtronic, Inc. devices

Submission Details

510(k) Number K181918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2018
Decision Date November 08, 2018
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 K181918.
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