Cleared Traditional

K891586 - ORAL AIRWAY

K891586 is an FDA 510(k) clearance for ORAL AIRWAY, manufactured by Dynarex Corp.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K891586 · Dynarex Corp. · Anesthesiology device
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May 1989
Decision
52d
Days
Class 1
Risk

K891586 is an FDA 510(k) clearance for the ORAL AIRWAY. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 52 days - a notably fast clearance 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: 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 Dynarex Corp. devices

FDA 510(k) Submission Details - K891586

510(k) Number K891586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date May 11, 1989
Days to Decision 52 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 140d · This submission: 52d
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 15
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K891586.
RUSCH OPTOSAFE
K960240 · Rusch Intl. · Apr 1996
GUEDEL AIRWAY
K953400 · Mallinckrodt Medical · Oct 1995
BERMAN AIRWAY
K936134 · Smiths Industries Medical Systems, Inc. · Jan 1994
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
K861540 · Dryden Corp. · May 1986
CURITY FIBEROPTIC INTUBATING AIRWAY
K855137 · The Kendal Co. · Mar 1986
DISPOSABLE GUEDEL AIRWAY
K850248 · Inmed Corp. · Mar 1985