Cleared Traditional

K810069 - STERILE AIRWAY

K810069 is an FDA 510(k) clearance for STERILE AIRWAY, manufactured by Medspec Corp.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K810069 · Medspec Corp. · Anesthesiology device
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Feb 1981
Decision
20d
Days
Class 1
Risk

K810069 is an FDA 510(k) clearance for the STERILE AIRWAY. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Medspec Corp. (Mchenry, US). The FDA issued a Cleared decision on February 2, 1981 after a review of 20 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 Medspec Corp. devices

FDA 510(k) Submission Details - K810069

510(k) Number K810069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date February 02, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 140d · This submission: 20d
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 23
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K810069.
ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III
K832471 · Inmed Corp. · Sep 1983
7CM BERMAN AIRWAY
K820512 · Vital Signs, Inc. · Mar 1982
AIRWAYS-OROPHARYNGEAL
K810099 · American Hospital Supply Corp. · Feb 1981
CONPHAR AIRWAYS
K791799 · Conphar, Inc. · Sep 1979
AIRWAYS
K780601 · Abco Dealers, Inc. · May 1978
AIRWAY, DUAL CHANNEL
K760488 · Hudson Oxygen Therapy Sales Co. · Sep 1976