Cleared Traditional

K904538 - MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K904538 · Mauna Loa Medical, Inc. · Anesthesiology device
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Apr 1991
Decision
202d
Days
Class 1
Risk

K904538 is an FDA 510(k) clearance for the MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Mauna Loa Medical, Inc. (Las Vegas, US). The FDA issued a Cleared decision on April 24, 1991 after a review of 202 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Mauna Loa Medical, Inc. devices

Submission Details

510(k) Number K904538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1990
Decision Date April 24, 1991
Days to Decision 202 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 139d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.