Cleared Traditional

K152223 - Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

K152223 is an FDA 510(k) clearance for Rectangular Multiplace Hyperbaric Chamb..., manufactured by Oxyheal Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K152223 · Oxyheal Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
266d
Days
Class 2
Risk

K152223 is an FDA 510(k) clearance for the Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscr.... Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Oxyheal Medical Systems, Inc. (National City, US). The FDA issued a Cleared decision on April 29, 2016 after a review of 266 days - an extended review cycle.

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. 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 - K152223

510(k) Number K152223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date April 29, 2016
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 140d · This submission: 266d
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 56
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K152223.
Revitalair 430+
K220290 · Us Hyperbaric Network · May 2023
Revitalair 430F
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OxyHeal 4000 Multiplace Hyperbaric Chamber Family
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SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
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RSI 4200
K102831 · Reimers Systems, Inc. · Aug 2011
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
K092991 · Environmental Tectonics Corp. · Aug 2010