Cleared Traditional

K012492 - KADANCE 2000

K012492 is an FDA 510(k) clearance for KADANCE 2000, manufactured by Kada Research, Inc.. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K012492 · Kada Research, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
91d
Days
Class 2
Risk

K012492 is an FDA 510(k) clearance for the KADANCE 2000. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Kada Research, Inc. (Houston, US). The FDA issued a Cleared decision on November 2, 2001 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1240 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kada Research, Inc. devices

FDA 510(k) Submission Details - K012492

510(k) Number K012492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2001
Decision Date November 02, 2001
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBB Device Classification - Class 2, Special Controls

Product Code LBB Dynamometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1240
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 Neurology devices follow this clearance model.

Regulatory Peers - LBB Dynamometer, Ac-powered

All 9
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K012492.
Hoggan Scientific® microFET2™
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ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
K980363 · Orofacial Dynamics · Apr 1998
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
K964933 · Mekanika, Inc. · Feb 1997
DYNAMOMETER
K964685 · John Chatillon & Sons, Inc. · Jan 1997
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
K901290 · Chattanooga Group, Inc. · Oct 1990