Cleared Special

K163109 - OxyHeal 4000 Multiplace Hyperbaric Chamber Family (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K163109 · Oxyheal Medical Systems, Inc. · Anesthesiology device
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Mar 2017
Decision
135d
Days
Class 2
Risk

K163109 is an FDA 510(k) clearance for the OxyHeal 4000 Multiplace Hyperbaric Chamber Family. 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 March 22, 2017 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Oxyheal Medical Systems, Inc. devices

Submission Details

510(k) Number K163109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2016
Decision Date March 22, 2017
Days to Decision 135 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 139d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.