Cleared Traditional

HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (K140096) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140096 · Hmicro, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 32
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K140096.
MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787 · Conmedcorp · Mar 1997
CONMED ECG/EKG ELECTRODES
K954389 · Conmedcorp · May 1996
CONMED EKG STRIPPER
K960264 · Conmedcorp · Apr 1996
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
K954388 · Conmedcorp · Feb 1996