Cleared Traditional

K191428 - ECG Cable (FDA 510(k) Clearance)

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

K191428 · Shenzhen Changke Connect Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
182d
Days
Class 2
Risk

K191428 is an FDA 510(k) clearance for the 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. (Longgang District, Shenzhen, CN). The FDA issued a Cleared decision on November 27, 2019 after a review of 182 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 Shenzhen Changke Connect Electronics Co., Ltd. devices

Submission Details

510(k) Number K191428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2019
Decision Date November 27, 2019
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 104
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K191428.
Baylis Connector Cable
K254114 · Baylis Medical Technologies, Inc. · Jan 2026
IBP cable Becton Dickinson (2606488)
K252827 · Dr?gerwerk AG & Co KGaA · Dec 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669 · Shanghai Draeger Medical Instrument Co., Ltd. · Sep 2025
SpO2 Extension Cable
K242986 · Beijing Rongrui-Century Science & Technology Co., Ltd. · May 2025
Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC
K243545 · Philips Medizin Systeme B?blingen GmbH · Jan 2025
RT Carbon ECG Leads
K240087 · Ivy Biomedical Systems, Inc. · Sep 2024