Cleared Traditional

THE DAVIS DISPOSABLE PROTECTIVE SPLINT (K924333) - FDA 510(k) Clearance

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

K924333 · Ora-Gard, Inc. · Neurology device
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Apr 1993
Decision
239d
Days
Class 2
Risk

K924333 is an FDA 510(k) clearance for the THE DAVIS DISPOSABLE PROTECTIVE SPLINT. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Ora-Gard, Inc. (Knoxville, US). The FDA issued a Cleared decision on April 23, 1993 after a review of 239 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - 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 Ora-Gard, Inc. devices

Submission Details

510(k) Number K924333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date April 23, 1993
Days to Decision 239 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
91d slower than avg
Panel avg: 148d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXL Block, Bite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5070
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.