Cleared Traditional

K852626 - AERO-MASK ONE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K852626 · Ashai Co. , Ltd. · Anesthesiology device
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Sep 1985
Decision
90d
Days
Class 1
Risk

K852626 is an FDA 510(k) clearance for the AERO-MASK ONE. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on September 18, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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 Ashai Co. , Ltd. devices

Submission Details

510(k) Number K852626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date September 18, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 139d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
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.