Cleared Traditional

K163316 - Multi-Link X2 ECG Adapter and Direct Co...

K163316 is an FDA 510(k) clearance for Multi-Link X2 ECG Adapter and Direct Co..., manufactured by Carefusion 303, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K163316 · Carefusion 303, Inc. · Cardiovascular device
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Jun 2017
Decision
211d
Days
Class 2
Risk

K163316 is an FDA 510(k) clearance for the Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Carefusion 303, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on June 22, 2017 after a review of 211 days - an extended review 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: 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 303, Inc. devices

FDA 510(k) Submission Details - K163316

510(k) Number K163316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2016
Decision Date June 22, 2017
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
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 51
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K163316.
Medline Patient Cables and Lead Wires
K181726 · Medline Industries, Inc. · Sep 2018
ECG Cable/Leadwires
K172797 · Shenzhen Coreray Technology, Ltd. · Feb 2018
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · Boston Scientific Corporation · Nov 2017
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · Boston Scientific · Dec 2013
PHILIPS ECG LEADWIRE SET
K110287 · Philips Medical Systems · Feb 2011
MULTLINK CABLE AND LEADWIRE SYSTEM
K082851 · Ge Medical Systems Information Technologies · Nov 2008