Cleared Traditional

K152947 - Disposable Temporary Pacing Cable

K152947 is an FDA 510(k) clearance for Disposable Temporary Pacing Cable, manufactured by Tiger Medical Products. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K152947 · Tiger Medical Products · Cardiovascular device
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Apr 2016
Decision
182d
Days
Class 2
Risk

K152947 is an FDA 510(k) clearance for the Disposable Temporary Pacing Cable. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Tiger Medical Products (Shanghai, CN). The FDA issued a Cleared decision on April 5, 2016 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 Tiger Medical Products devices

FDA 510(k) Submission Details - K152947

510(k) Number K152947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2015
Decision Date April 05, 2016
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.

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 57
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K152947.
Medline Patient Cables and Lead Wires
K181726 · Medline Industries, Inc. · Sep 2018
ECG Cable/Leadwires
K172797 · Shenzhen Coreray Technology, Ltd. · Feb 2018
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · Boston Scientific Corporation · Nov 2017
Unimed Disposable ECG lead wires
K142489 · Unimed Medical Supplies, Inc. · Nov 2014
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · Boston Scientific · Dec 2013
PHILIPS ECG LEADWIRE SET
K110287 · Philips Medical Systems · Feb 2011