Cleared Traditional

K140096 - HMICRO WIRED C-PATCH ELECTRODE

K140096 is an FDA 510(k) clearance for HMICRO WIRED C-PATCH ELECTRODE, manufactured by Hmicro, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K140096 · Hmicro, Inc. · Cardiovascular device
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Jul 2014
Decision
191d
Days
Class 2
Risk

K140096 is an FDA 510(k) clearance for the HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Hmicro, Inc. (Los Altos, US). The FDA issued a Cleared decision on July 24, 2014 after a review of 191 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Hmicro, Inc. devices

FDA 510(k) Submission Details - K140096

510(k) Number K140096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2014
Decision Date July 24, 2014
Days to Decision 191 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
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 131
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K140096.
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MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006
AMBU DISPOSABLE ECG ELECTRODE
K041734 · Ambu, Inc. · Sep 2004