Cleared Traditional

K884294 - NICOLET NYSTAR PLUS SYSTEM

K884294 is an FDA 510(k) clearance for NICOLET NYSTAR PLUS SYSTEM, manufactured by Nicolet Instrument Corp.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K884294 · Nicolet Instrument Corp. · Neurology device
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Nov 1988
Decision
42d
Days
Class 2
Risk

K884294 is an FDA 510(k) clearance for the NICOLET NYSTAR PLUS SYSTEM. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Nicolet Instrument Corp. (Madison, US). The FDA issued a Cleared decision on November 23, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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 Nicolet Instrument Corp. devices

FDA 510(k) Submission Details - K884294

510(k) Number K884294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date November 23, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 148d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 17
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