Cleared Traditional

K852622 - AEROSOL ONE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852622 · Ashai Co. , Ltd. · Anesthesiology device
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Apr 1986
Decision
308d
Days
Class 2
Risk

K852622 is an FDA 510(k) clearance for the AEROSOL ONE. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on April 24, 1986 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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. Elevated predicate reliance profile. 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 K852622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date April 24, 1986
Days to Decision 308 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 139d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.