Cleared Traditional

OXY-BLOC (K931044) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K931044 · Gi Supply · Gastroenterology & Urology device
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Oct 1993
Decision
217d
Days
Class 1
Risk

K931044 is an FDA 510(k) clearance for the OXY-BLOC. Classified as Endoscopic Bite Block (product code MNK), Class I - General Controls.

Submitted by Gi Supply (Camp Hill, US). The FDA issued a Cleared decision on October 4, 1993 after a review of 217 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K931044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1993
Decision Date October 04, 1993
Days to Decision 217 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
87d slower than avg
Panel avg: 130d · This submission: 217d
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.