Cleared Traditional

K160210 - EnSite Precision Cardiac Mapping System v2.0

K160210 is an FDA 510(k) clearance for EnSite Precision Cardiac Mapping System..., manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K160210 · St Jude Medical · Cardiovascular device
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Dec 2016
Decision
320d
Days
Class 2
Risk

K160210 is an FDA 510(k) clearance for the EnSite Precision Cardiac Mapping System v2.0. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by St Jude Medical (St. Paul, US). The FDA issued a Cleared decision on December 13, 2016 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 St Jude Medical devices

FDA 510(k) Submission Details - K160210

510(k) Number K160210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2016
Decision Date December 13, 2016
Days to Decision 320 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
195d slower than avg
Panel avg: 125d · This submission: 320d
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 370
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K160210.
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