Cleared Special

K100315 - 12 LEAD GLOVE

K100315 is an FDA 510(k) clearance for 12 LEAD GLOVE, manufactured by I Needmd, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Special 510(k) pathway after a 78-day FDA review.

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.

FDA 510(k) Submission Details - K100315

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.

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 297
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K100315 · 12 LEAD GLOVE
Download PDF I Needmd, Inc.