Cleared Traditional

K030418 - MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM

K030418 is an FDA 510(k) clearance for MULTIPLACE HYPERBARIC SYSTEM, manufactured by Makai Marine Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K030418 · Makai Marine Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
353d
Days
Class 2
Risk

K030418 is an FDA 510(k) clearance for the MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Makai Marine Industries, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 29, 2004 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - 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.

FDA 510(k) Submission Details - K030418

510(k) Number K030418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2003
Decision Date January 29, 2004
Days to Decision 353 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 140d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
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.

Regulatory Peers - CBF Chamber, Hyperbaric

All 67
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K030418.
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
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MILLENIUM, MODELS 2000, 2001 AND 2002
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BAY AREA HYPERSCIENCES
K030713 · Bay Area Hypersciences, LLC · Dec 2003
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
K031649 · Fink Engineering Pty, Ltd. · Dec 2003
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
K022214 · Mechidyne Systems, Inc. · Feb 2003
K030418 · MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
Download PDF FDA Summary Makai Marine Industri…