Cleared Traditional

K883766 - MOUTH-TO-MASK VENTILATORY ADJUNCT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K883766 · Medic One · Anesthesiology device
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Oct 1988
Decision
45d
Days
Class 1
Risk

K883766 is an FDA 510(k) clearance for the MOUTH-TO-MASK VENTILATORY ADJUNCT. Classified as Mask, Oxygen, Non-rebreathing (product code KGB), Class I - General Controls.

Submitted by Medic One (Independence, US). The FDA issued a Cleared decision on October 21, 1988 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5570 - 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 Medic One devices

Submission Details

510(k) Number K883766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1988
Decision Date October 21, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 139d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGB Mask, Oxygen, Non-rebreathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5570
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.