Cleared Traditional

K810539 - MODEL S10CTCM AUDITORY STIMULATOR

K810539 is the FDA 510(k) clearance for MODEL S10CTCM AUDITORY STIMULATOR by Grass Instrument Co.. It is a Class 2 Neurology device (product code GWJ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K810539 · Grass Instrument Co. · Neurology device
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Mar 1981
Decision
18d
Days
Class 2
Risk

K810539 is an FDA 510(k) clearance for the MODEL S10CTCM AUDITORY STIMULATOR. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Grass Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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

Submission Details

510(k) Number K810539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1981
Decision Date March 17, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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.