Cleared Traditional

K153188 - Caremed patient cable and leadwires

K153188 is an FDA 510(k) clearance for Caremed patient cable and leadwires, manufactured by Shenzhen Caremed Medical Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K153188

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
Combination Product No
PCCP Authorized No
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.

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 71
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K153188.
Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
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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
Disposable Temporary Pacing Cable
K152947 · Tiger Medical Products · Apr 2016
Unimed Disposable ECG lead wires
K142489 · Unimed Medical Supplies, Inc. · Nov 2014
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · Boston Scientific · Dec 2013