Cleared Traditional

K182327 - Patient Cables and Leadwires , Disposable ECG Leadwires

K182327 is an FDA 510(k) clearance for Patient Cables and Leadwires, manufactured by Orantech, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K182327 · Orantech, Inc. · Cardiovascular device
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Jan 2019
Decision
156d
Days
Class 2
Risk

K182327 is an FDA 510(k) clearance for the Patient Cables and Leadwires , Disposable ECG Leadwires. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Orantech, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on January 30, 2019 after a review of 156 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 Orantech, Inc. devices

FDA 510(k) Submission Details - K182327

510(k) Number K182327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2018
Decision Date January 30, 2019
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
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 71
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K182327.
ECG Cable
K191428 · Shenzhen Changke Connect Electronics Co., Ltd. · Nov 2019
Multi-Link X2 ECG and SpO2 Adapter
K191273 · Vyaire Medical, Inc. · Sep 2019
IntraSight
K190078 · Volcano Corporation · Feb 2019
Curbell branded Patient Monitoring Cables
K182220 · Curbell Medical Products, Inc. · Nov 2018
Medline Patient Cables and Lead Wires
K181726 · Medline Industries, Inc. · Sep 2018
ECG Cable/Leadwires
K172797 · Shenzhen Coreray Technology, Ltd. · Feb 2018