Cleared Traditional

K841612 - NEUROPACK II 5100

K841612 is an FDA 510(k) clearance for NEUROPACK II 5100, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K841612 · Nihon Kohden America, Inc. · Neurology device
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Jun 1984
Decision
58d
Days
Class 2
Risk

K841612 is an FDA 510(k) clearance for the NEUROPACK II 5100. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on June 7, 1984 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K841612

510(k) Number K841612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1984
Decision Date June 07, 1984
Days to Decision 58 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 148d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 18
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K841612.
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · Nihon Kohden America, Inc. · Sep 1988
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · Nihon Kohden America, Inc. · Sep 1987
NICOLET AMP 6R11 SYSTEM
K871678 · Nicolet Biomedical Instruments · Jul 1987
AMPLIFIER OTRONA, MODEL N3A-EMG
K772102 · Honeywell, Inc. · Nov 1977
AMPLIFIER MODEL N3B-EEG
K771683 · Honeywell, Inc. · Sep 1977