Cleared Traditional

K162432 - Multi-Link X2 ECG Cable and Lead Wire System

K162432 is an FDA 510(k) clearance for Multi-Link X2 ECG Cable and Lead Wire S..., manufactured by Carefusion 2200, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K162432 · Carefusion 2200, Inc. · Cardiovascular device
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Jan 2017
Decision
140d
Days
Class 2
Risk

K162432 is an FDA 510(k) clearance for the Multi-Link X2 ECG Cable and Lead Wire System. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Carefusion 2200, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on January 18, 2017 after a review of 140 days - within the typical 510(k) review window.

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: 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 Carefusion 2200, Inc. devices

FDA 510(k) Submission Details - K162432

510(k) Number K162432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2016
Decision Date January 18, 2017
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 83
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K162432.
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Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
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ECG Disposable Lead Wire
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Caremed patient cable and leadwires
K153188 · Shenzhen Caremed Medical Technology Co., Ltd. · Oct 2016
Disposable Temporary Pacing Cable
K152947 · Tiger Medical Products · Apr 2016
Unimed Disposable ECG lead wires
K142489 · Unimed Medical Supplies, Inc. · Nov 2014