Cleared Traditional

K152223 - Rectangular Multiplace Hyperbaric Chamb...

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
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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.

View all Oxyheal Medical Systems, Inc. devices

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
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 10
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K152223.
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