Cleared Traditional

K071631 - NICOM ELECTRODES

K071631 is an FDA 510(k) clearance for NICOM ELECTRODES, manufactured by Cheetah Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K071631 · Cheetah Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
218d
Days
Class 2
Risk

K071631 is an FDA 510(k) clearance for the NICOM ELECTRODES. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Cheetah Medical, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on January 18, 2008 after a review of 218 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Cheetah Medical, Inc. devices

FDA 510(k) Submission Details - K071631

510(k) Number K071631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2007
Decision Date January 18, 2008
Days to Decision 218 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
93d slower than avg
Panel avg: 125d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 97
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