Cleared Traditional

K200510 - Multi-LinkTM X2 ECG Adapter and Leadwires

K200510 is an FDA 510(k) clearance for Multi-LinkTM X2 ECG Adapter and Leadwires, manufactured by Vyaire Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K200510 · Vyaire Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
221d
Days
Class 2
Risk

K200510 is an FDA 510(k) clearance for the Multi-LinkTM X2 ECG Adapter and Leadwires. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Vyaire Medical, Inc. (Mettawa, US). The FDA issued a Cleared decision on October 9, 2020 after a review of 221 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 Vyaire Medical, Inc. devices

FDA 510(k) Submission Details - K200510

510(k) Number K200510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date October 09, 2020
Days to Decision 221 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
96d slower than avg
Panel avg: 125d · This submission: 221d
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 K200510.
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
K203556 · Medtronic, Inc. · Jul 2021
PCA-C1 series Patient Cable
K200722 · QT Medical, Inc. · Jun 2021
Patient Monitoring Cables
K203635 · Jkh USA, LLC · Feb 2021
ECG Cables and Leadwires
K201359 · Xinkang Medical Instrument Co. , Ltd. · Oct 2020
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
K200674 · Atrility Medical, LLC · Jul 2020
Patient Monitoring Cable (SpO2 Extension Cable)
K192404 · Shenzhen Coreray Technology, Ltd. · Jun 2020