Cleared Traditional

K002869 - LOCALISA CARDIAC NAVIGATION SYSTEM

K002869 is an FDA 510(k) clearance for LOCALISA CARDIAC NAVIGATION SYSTEM, manufactured by Medtronic Surgical Navigation Technologies. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K002869 · Medtronic Surgical Navigation Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
195d
Days
Class 2
Risk

K002869 is an FDA 510(k) clearance for the LOCALISA CARDIAC NAVIGATION SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Medtronic Surgical Navigation Technologies (Shoreview, US). The FDA issued a Cleared decision on March 27, 2001 after a review of 195 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 Medtronic Surgical Navigation Technologies devices

FDA 510(k) Submission Details - K002869

510(k) Number K002869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2000
Decision Date March 27, 2001
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
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 362
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K002869.
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · Cambridge Heart, Inc. · May 2001
SYNETEC
K002817 · Ela Medical, Inc. · May 2001
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K010756 · Cambridge Heart, Inc. · Apr 2001
ASTRONOMER+WITH SLD
K003362 · Boston Scientific Corp · Mar 2001
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING
K003492 · Cambridge Heart, Inc. · Jan 2001
CATHCOR DESKTOP
K002137 · Siemens Elema AB · Oct 2000