Cleared Traditional

K812061 - MODEL S10VS VISUAL STIMULATOR

K812061 is an FDA 510(k) clearance for MODEL S10VS VISUAL STIMULATOR, manufactured by Grass Instrument Co.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K812061 · Grass Instrument Co. · Neurology device
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Aug 1981
Decision
30d
Days
Class 2
Risk

K812061 is an FDA 510(k) clearance for the MODEL S10VS VISUAL STIMULATOR. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Grass Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1981 after a review of 30 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 Grass Instrument Co. devices

FDA 510(k) Submission Details - K812061

510(k) Number K812061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date August 20, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
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 30
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K812061.
SLS 3500 LED VISUAL STIMULATOR
K842381 · Nihon Kohden America, Inc. · Nov 1984
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
STIMULATOR, NIC-106 VISUAL
K790570 · Nicolet Biomedical Instruments · May 1979
MODEL 7320 VISUAL STIMULATOR
K781461 · Life-Tech Instruments, Inc. · Nov 1978