Cleared Traditional

K120010 - CABLE/ LEAD-WIRE (ECG

K120010 is an FDA 510(k) clearance for CABLE/ LEAD-WIRE (ECG, manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K120010 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
16d
Days
Class 2
Risk

K120010 is an FDA 510(k) clearance for the CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE). Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on January 19, 2012 after a review of 16 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Med-Link Electronics Tech Co., Ltd. devices

FDA 510(k) Submission Details - K120010

510(k) Number K120010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date January 19, 2012
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K120010.
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
COMPATIBILITY ECG TRUNK CABLES
K043572 · Datex-Ohmeda · Feb 2005