Cleared Traditional

K921138 - NICOLET ULTRASOM ACQUISITION STATION

K921138 is an FDA 510(k) clearance for NICOLET ULTRASOM ACQUISITION STATION, manufactured by Nicolet Instrument Corp.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K921138 · Nicolet Instrument Corp. · Neurology device
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May 1993
Decision
430d
Days
Class 2
Risk

K921138 is an FDA 510(k) clearance for the NICOLET ULTRASOM ACQUISITION STATION. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Nicolet Instrument Corp. (Madison, US). The FDA issued a Cleared decision on May 14, 1993 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Nicolet Instrument Corp. devices

FDA 510(k) Submission Details - K921138

510(k) Number K921138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1992
Decision Date May 14, 1993
Days to Decision 430 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
281d slower than avg
Panel avg: 149d · This submission: 430d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 164
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