Cleared Special

12 LEAD GLOVE (K100315) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K100315 · I Needmd, Inc. · Cardiovascular device
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Apr 2010
Decision
78d
Days
Class 2
Risk

K100315 is an FDA 510(k) clearance for the 12 LEAD GLOVE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by I Needmd, Inc. (New York, US). The FDA issued a Cleared decision on April 23, 2010 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all I Needmd, Inc. devices

Submission Details

510(k) Number K100315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2010
Decision Date April 23, 2010
Days to Decision 78 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

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 328
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K100315.
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RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
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K891075 · C.R. Bard, Inc. · Mar 1989