Cleared Traditional

K761297 - MOUTHPIECE SEAL (FDA 510(k) Clearance)

Class I Anesthesiology device.

K761297 · Oem Medical Div. · Anesthesiology device
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Jan 1977
Decision
13d
Days
Class 1
Risk

K761297 is an FDA 510(k) clearance for the MOUTHPIECE SEAL. Classified as Mouthpiece, Breathing (product code BYP), Class I - General Controls.

Submitted by Oem Medical Div. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1977 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5620 - the FDA anesthesiology and respiratory 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 Oem Medical Div. devices

Submission Details

510(k) Number K761297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1976
Decision Date January 03, 1977
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 139d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYP Mouthpiece, Breathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5620
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.