Cleared Traditional

K860240 - CNS-EP SYSTEM AND EP 1.0 SOFTWARE

K860240 is the FDA 510(k) clearance for CNS-EP SYSTEM AND EP 1.0 SOFTWARE by Cns, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K860240 · Cns, Inc. · Neurology device
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Apr 1986
Decision
84d
Days
Class 2
Risk

K860240 is an FDA 510(k) clearance for the CNS-EP SYSTEM AND EP 1.0 SOFTWARE. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Cns, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on April 17, 1986 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cns, Inc. devices

Submission Details

510(k) Number K860240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1986
Decision Date April 17, 1986
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 148d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K860240.
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
K950208 · Nihon Kohden America, Inc. · May 1995
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · Nihon Kohden America, Inc. · Feb 1992
MEM-7102
K890274 · Nihon Kohden America, Inc. · May 1989
NEUROPACK 8, MEE-4108
K851300 · Nihon Kohden America, Inc. · Jun 1985