Cleared Traditional

BOOST, MICE, GAMESYS. (K924416) - FDA 510(k) Clearance

Class I Neurology device.

K924416 · Penny and Giles Biometrics , Ltd. · Neurology device
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Jun 1993
Decision
288d
Days
Class 1
Risk

K924416 is an FDA 510(k) clearance for the BOOST, MICE, GAMESYS.. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Penny and Giles Biometrics , Ltd. (England, GB). The FDA issued a Cleared decision on June 15, 1993 after a review of 288 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - 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 Penny and Giles Biometrics , Ltd. devices

Submission Details

510(k) Number K924416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date June 15, 1993
Days to Decision 288 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
140d slower than avg
Panel avg: 148d · This submission: 288d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.