Cleared Traditional

K113214 - TLINK DATA MANAGEMENT SYSTEM (DMS) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113214 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Feb 2012
Decision
99d
Days
Class 2
Risk

K113214 is an FDA 510(k) clearance for the TLINK DATA MANAGEMENT SYSTEM (DMS). Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Ann Arbor, US). The FDA issued a Cleared decision on February 7, 2012 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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 Terumo Cardiovascular Systems Corp. devices

Submission Details

510(k) Number K113214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date February 07, 2012
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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.