Cleared Traditional

K924127 - DANTEC EVOLUTION

K924127 is an FDA 510(k) clearance for DANTEC EVOLUTION, manufactured by Dantec Medical, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K924127 · Dantec Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
205d
Days
Class 2
Risk

K924127 is an FDA 510(k) clearance for the DANTEC EVOLUTION. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on March 10, 1993 after a review of 205 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Dantec Medical, Inc. devices

FDA 510(k) Submission Details - K924127

510(k) Number K924127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1992
Decision Date March 10, 1993
Days to Decision 205 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 slower than avg
Panel avg: 148d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 55
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K924127.
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
K950208 · Nihon Kohden America, Inc. · May 1995
CADWELL 6200 A
K931428 · Cadwell Laboratories, Inc. · Jun 1993
CADWELL SIERRA
K924723 · Cadwell Laboratories, Inc. · Mar 1993
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · Nihon Kohden America, Inc. · Feb 1992
HIGH SPEED MAGNETIC STIMULATOR
K905059 · Cadwell Laboratories, Inc. · Sep 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · Teca, Inc. · Feb 1991