Cleared Traditional

K153188 - Caremed patient cable and leadwires

K153188 is the FDA 510(k) clearance for Caremed patient cable and leadwires by Shenzhen Caremed Medical Technology Co., Ltd.. It is a Class 2 Cardiovascular device (product code DSA) cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K153188 · Shenzhen Caremed Medical Technology Co., Ltd. · Cardiovascular device
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Oct 2016
Decision
356d
Days
Class 2
Risk

K153188 is an FDA 510(k) clearance for the Caremed patient cable and leadwires. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Shenzhen Caremed Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 24, 2016 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Shenzhen Caremed Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K153188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2015
Decision Date October 24, 2016
Days to Decision 356 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
231d slower than avg
Panel avg: 125d · This submission: 356d
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 Peers - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 48
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K153188.
Medline Patient Cables and Lead Wires
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ECG Cable/Leadwires
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K172591 · Boston Scientific Corporation · Nov 2017
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · Boston Scientific · Dec 2013
PHILIPS ECG LEADWIRE SET
K110287 · Philips Medical Systems · Feb 2011
MULTLINK CABLE AND LEADWIRE SYSTEM
K082851 · Ge Medical Systems Information Technologies · Nov 2008