Cleared Traditional

K790570 - STIMULATOR, NIC-106 VISUAL

K790570 is an FDA 510(k) clearance for STIMULATOR, manufactured by Nicolet Biomedical Instruments. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K790570 · Nicolet Biomedical Instruments · Neurology device
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May 1979
Decision
61d
Days
Class 2
Risk

K790570 is an FDA 510(k) clearance for the STIMULATOR, NIC-106 VISUAL. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Mchenry, US). The FDA issued a Cleared decision on May 23, 1979 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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 Biomedical Instruments devices

FDA 510(k) Submission Details - K790570

510(k) Number K790570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1979
Decision Date May 23, 1979
Days to Decision 61 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
87d faster than avg
Panel avg: 148d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 28
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K790570.
LED STIMULATOR LS-05
K834442 · Teca, Inc. · Aug 1984
BIOLOGIC SYSTEM BL 101
K831047 · Bio-Logic Systems Corp. · May 1983
STIMULATOR MODEL SSS-1101
K791149 · Nihon Kohden America, Inc. · Sep 1979
MODEL 7320 VISUAL STIMULATOR
K781461 · Life-Tech Instruments, Inc. · Nov 1978
TECA VS6 VIDEO STIMULATOR
K781398 · Teca, Inc. · Aug 1978