Cleared Traditional

Multi-LinkTM X2 ECG Adapter and Leadwires (K200510) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 40
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