Cleared Traditional

K904834 - INTAVENT LARYNGEAL MASK

K904834 is an FDA 510(k) clearance for INTAVENT LARYNGEAL MASK, manufactured by Intavent Intl. S.A.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K904834 · Intavent Intl. S.A. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K904834

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
135d slower than avg
Panel avg: 140d · This submission: 275d
Pathway characteristics
Predicate-based equivalence.

CAE Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAE Airway, Oropharyngeal, Anesthesiology

All 25
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K904834.
STB GUEDEL AIRWAY
K933760 · Save-T-Breath Distributors C.C. · Mar 1994
BERMAN AIRWAY
K936134 · Smiths Industries Medical Systems, Inc. · Jan 1994
GUEDEL AIRWAY
K922748 · Oem Medical Div. · Jul 1992
ORAL AIRWAY
K891586 · Dynarex Corp. · May 1989
DUAL-AID
K860949 · Vitalograph , Ltd. · May 1986
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
K861540 · Dryden Corp. · May 1986
K904834 · INTAVENT LARYNGEAL MASK
Download PDF Intavent Intl. S.A.