Cleared Traditional

K170536 - ECG Disposable Lead Wire

K170536 is an FDA 510(k) clearance for ECG Disposable Lead Wire, manufactured by APK Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K170536 · APK Technology Co., Ltd. · Cardiovascular device
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Apr 2017
Decision
60d
Days
Class 2
Risk

K170536 is an FDA 510(k) clearance for the ECG Disposable Lead Wire. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by APK Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 24, 2017 after a review of 60 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 APK Technology Co., Ltd. devices

FDA 510(k) Submission Details - K170536

510(k) Number K170536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2017
Decision Date April 24, 2017
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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 83
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K170536.
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · Boston Scientific Corporation · Nov 2017
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K162768 · Integral Process Sas · Aug 2017
Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
K163316 · Carefusion 303, Inc. · Jun 2017
Multi-Link X2 ECG Cable and Lead Wire System
K162432 · Carefusion 2200, Inc. · Jan 2017
Caremed patient cable and leadwires
K153188 · Shenzhen Caremed Medical Technology Co., Ltd. · Oct 2016
Disposable Temporary Pacing Cable
K152947 · Tiger Medical Products · Apr 2016