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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Delphi Medical Device Consulting, Inc.
Pamela Papineau

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 94
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K152947.
ECG Disposable Lead Wire
K170536 · APK Technology Co., Ltd. · Apr 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
Unimed Disposable ECG lead wires
K142489 · Unimed Medical Supplies, Inc. · Nov 2014
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · Boston Scientific · Dec 2013
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
K120010 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 2012
K152947 · Disposable Temporary Pacing Cable
Download PDF FDA Summary Tiger Medical Products