Cleared Traditional

K163008 - CareLink SmartSync Device Manager - Pac...

K163008 is an FDA 510(k) clearance for CareLink SmartSync Device Manager - Pac..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DTA cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K163008 · Medtronic, Inc. · Cardiovascular device
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Feb 2017
Decision
123d
Days
Class 2
Risk

K163008 is an FDA 510(k) clearance for the CareLink SmartSync Device Manager - Pacing System Analyzer. Classified as Tester, Pacemaker Electrode Function (product code DTA), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on February 28, 2017 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3720 - 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

FDA 510(k) Submission Details - K163008

510(k) Number K163008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date February 28, 2017
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTA Device Classification - Class 2, Special Controls

Product Code DTA Tester, Pacemaker Electrode Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3720
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 - DTA Tester, Pacemaker Electrode Function

Devices cleared under the same product code (DTA) and FDA review panel - the closest regulatory comparables to K163008.
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
K073230 · Biotronik, Inc. · Dec 2007
ADAPTER CABLE
K050884 · Remington Medical, Inc. · May 2005
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K033613 · Biotronik, Inc. · Dec 2003
ERA 3000
K022360 · Biotronik, Inc. · Jan 2003
SIEMENS-ELEMA PSA 376
K812104 · Siemens Corp. · Dec 1981
CARDIOTEST 2200
K790503 · Cardiac Pacemakers, Inc. · May 1979