Cleared Traditional

OXYGEN MOUTHGUARD (K944049) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K944049 · Endovations, Inc. · Gastroenterology & Urology device
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Oct 1994
Decision
54d
Days
Class 1
Risk

K944049 is an FDA 510(k) clearance for the OXYGEN MOUTHGUARD. Classified as Endoscopic Bite Block (product code MNK), Class I - General Controls.

Submitted by Endovations, Inc. (Reading, US). The FDA issued a Cleared decision on October 11, 1994 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Endovations, Inc. devices

Submission Details

510(k) Number K944049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1994
Decision Date October 11, 1994
Days to Decision 54 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 130d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNK Endoscopic Bite Block
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
Definition To Prevent Patient From Biting Down In Order To Protect Fragile Endoscope Equipment, Patient's Teeth And Gums, And Endscopist's Fingers When Inserting Endoscope Orally.
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.