Cleared Traditional

K800369 - TRI PAC MOUTH PROP (FDA 510(k) Clearance)

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

K800369 · Oxequip Health Ind. · Neurology device
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Feb 1980
Decision
8d
Days
Class 2
Risk

K800369 is an FDA 510(k) clearance for the TRI PAC MOUTH PROP. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Oxequip Health Ind. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1980 after a review of 8 days - a notably fast clearance 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: 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 Oxequip Health Ind. devices

Submission Details

510(k) Number K800369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1980
Decision Date February 28, 1980
Days to Decision 8 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d faster than avg
Panel avg: 148d · This submission: 8d
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.