Cleared Traditional

K904538 - MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT

K904538 is an FDA 510(k) clearance for MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT, manufactured by Mauna Loa Medical, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 202-day FDA review.

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.

FDA 510(k) Submission Details - K904538

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
62d slower than avg
Panel avg: 140d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 140
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K904538.
BODAI NEO2 -SAFE AIRWAY PRESSURE CAP
K913753 · B&B Medical Technologies, Inc. · Oct 1991
22MM ID/OD ADAPTER
K911263 · Monaghan Medical Corp. · Aug 1991
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
K905450 · Vital Signs, Inc. · Jul 1991
VENTLAB ANESTHESIA CIRCUIT AC 6000
K896897 · Ventlab Corp. · Jan 1990
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · Baxter Healthcare Corp · Jan 1990
ANETHESIA BREATHING CIRCUIT
K895357 · F.L.W. Plastics, Inc. · Oct 1989
K904538 · MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT
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