Cleared Traditional

K782036 - TREMOR MONITOR (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K782036 · Columbus Instruments Intl. Corp. · Neurology device
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Jan 1979
Decision
49d
Days
Class 2
Risk

K782036 is an FDA 510(k) clearance for the TREMOR MONITOR. Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by Columbus Instruments Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1950 - 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 Columbus Instruments Intl. Corp. devices

Submission Details

510(k) Number K782036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1978
Decision Date January 23, 1979
Days to Decision 49 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 148d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYD Transducer, Tremor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1950
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 - GYD Transducer, Tremor

All 11
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