Cleared Traditional

K904834 - INTAVENT LARYNGEAL MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K904834 · Intavent Intl. S.A. · Anesthesiology device
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Jul 1991
Decision
275d
Days
Class 1
Risk

K904834 is an FDA 510(k) clearance for the INTAVENT LARYNGEAL MASK. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Intavent Intl. S.A. (England, GB). The FDA issued a Cleared decision on July 26, 1991 after a review of 275 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intavent Intl. S.A. devices

Submission Details

510(k) Number K904834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1990
Decision Date July 26, 1991
Days to Decision 275 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 139d · This submission: 275d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
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.