Cleared Traditional

K844956 - AVA-MIST PORTABLE AIR COMPRESSOR

K844956 is the FDA 510(k) clearance for AVA-MIST PORTABLE AIR COMPRESSOR by Avatron, Inc.. It is a Class 2 Anesthesiology device (product code BTI) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K844956 · Avatron, Inc. · Anesthesiology device
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Feb 1985
Decision
55d
Days
Class 2
Risk

K844956 is an FDA 510(k) clearance for the AVA-MIST PORTABLE AIR COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Avatron, Inc. (Benicia, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 55 days - a notably fast clearance cycle.

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: 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 Avatron, Inc. devices

Submission Details

510(k) Number K844956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1984
Decision Date February 14, 1985
Days to Decision 55 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 140d · This submission: 55d
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.