Cleared Traditional

K182327 - Patient Cables and Leadwires

K182327 is the FDA 510(k) clearance for Patient Cables and Leadwires by Orantech, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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

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 47
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