Cleared Traditional

OXYGUARD (K914978) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K914978 · Stantex Pty , Ltd. · Gastroenterology & Urology device
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Jan 1992
Decision
65d
Days
Class 1
Risk

K914978 is an FDA 510(k) clearance for the OXYGUARD. Classified as Endoscopic Bite Block (product code MNK), Class I - General Controls.

Submitted by Stantex Pty , Ltd. (Sydney, New South Wales, AU). The FDA issued a Cleared decision on January 10, 1992 after a review of 65 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 Stantex Pty , Ltd. devices

Submission Details

510(k) Number K914978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1991
Decision Date January 10, 1992
Days to Decision 65 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
65d faster than avg
Panel avg: 130d · This submission: 65d
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.