Cleared Traditional

K915652 - NICOLET PORATBLE SPIRIT SYSTEM

K915652 is an FDA 510(k) clearance for NICOLET PORATBLE SPIRIT SYSTEM, manufactured by Nicolet Instrument Corp.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K915652 · Nicolet Instrument Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
51d
Days
Class 2
Risk

K915652 is an FDA 510(k) clearance for the NICOLET PORATBLE SPIRIT SYSTEM. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nicolet Instrument Corp. (Madison, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 51 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 Nicolet Instrument Corp. devices

FDA 510(k) Submission Details - K915652

510(k) Number K915652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date February 07, 1992
Days to Decision 51 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
98d faster than avg
Panel avg: 149d · This submission: 51d
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 113
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K915652.
SAPPHIRE PREMIERE
K923303 · Medelec , Ltd. · Nov 1992
NICOLET ARK SYSTEM
K923315 · Nicolet Instrument Corp. · Nov 1992
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
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
K902607 · Dantec Medical, Inc. · May 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · Teca, Inc. · Feb 1991