Cleared Traditional

K861540 - DISPOSABLE BERMAN AND GUEDEL AIRWAYS

K861540 is an FDA 510(k) clearance for DISPOSABLE BERMAN AND GUEDEL AIRWAYS, manufactured by Dryden Corp.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K861540 · Dryden Corp. · Anesthesiology device
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May 1986
Decision
8d
Days
Class 1
Risk

K861540 is an FDA 510(k) clearance for the DISPOSABLE BERMAN AND GUEDEL AIRWAYS. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Dryden Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 8 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 Dryden Corp. devices

FDA 510(k) Submission Details - K861540

510(k) Number K861540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1986
Decision Date May 02, 1986
Days to Decision 8 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
132d faster than avg
Panel avg: 140d · This submission: 8d
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 20
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K861540.
BERMAN AIRWAY
K936134 · Smiths Industries Medical Systems, Inc. · Jan 1994
ORAL AIRWAY
K891586 · Dynarex Corp. · May 1989
DUAL-AID
K860949 · Vitalograph , Ltd. · May 1986
DISPOSABLE RESCUE BREATHING DEVICE
K861054 · B & F Medical Products, Inc. · Apr 1986
CURITY FIBEROPTIC INTUBATING AIRWAY
K855137 · The Kendal Co. · Mar 1986
DISPOSABLE GUEDEL AIRWAY
K850248 · Inmed Corp. · Mar 1985