Cleared Traditional

Disposable ECG Cable (K200026) - FDA 510(k) Clearance

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

K200026 · Shenzhen Changke Connect Electronics Co., Ltd. · Cardiovascular device
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May 2020
Decision
127d
Days
Class 2
Risk

K200026 is an FDA 510(k) clearance for the Disposable ECG Cable. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Shenzhen Changke Connect Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 12, 2020 after a review of 127 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 Shenzhen Changke Connect Electronics Co., Ltd. devices

Submission Details

510(k) Number K200026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2020
Decision Date May 12, 2020
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 Consultant

Chonconn Medical Device Consulting Co., Ltd.
Kevin Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K200026.
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
SureLead Cable System
K181089 · Authentic Medical · Jan 2020
ECG Cable
K191428 · Shenzhen Changke Connect Electronics Co., Ltd. · Nov 2019
Multi-Link X2 ECG and SpO2 Adapter
K191273 · Vyaire Medical, Inc. · Sep 2019