Cleared Traditional

MM-1 MOVEMENT MONITOR (K971318) - FDA 510(k) Clearance

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

K971318 · Axon Instruments, Inc. · Neurology device
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Jul 1997
Decision
110d
Days
Class 2
Risk

K971318 is an FDA 510(k) clearance for the MM-1 MOVEMENT MONITOR. Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by Axon Instruments, Inc. (Foster City, US). The FDA issued a Cleared decision on July 28, 1997 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Axon Instruments, Inc. devices

Submission Details

510(k) Number K971318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1997
Decision Date July 28, 1997
Days to Decision 110 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
38d faster than avg
Panel avg: 148d · This submission: 110d
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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