Cleared Traditional

K082851 - MULTLINK CABLE AND LEADWIRE SYSTEM

K082851 is an FDA 510(k) clearance for MULTLINK CABLE AND LEADWIRE SYSTEM, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K082851 · Ge Medical Systems Information Technologies · Cardiovascular device
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Nov 2008
Decision
51d
Days
Class 2
Risk

K082851 is an FDA 510(k) clearance for the MULTLINK CABLE AND LEADWIRE SYSTEM. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on November 19, 2008 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K082851

510(k) Number K082851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date November 19, 2008
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 50
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K082851.
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