Cleared Special

K163109 - OxyHeal 4000 Multiplace Hyperbaric Chamber Family

K163109 is an FDA 510(k) clearance for OxyHeal 4000 Multiplace Hyperbaric Cham..., manufactured by Oxyheal Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Special 510(k) pathway after a 135-day FDA review.

K163109 · Oxyheal Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K163109

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 140d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

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 K163109.
FESL FINK Chamber
K240569 · Fink Engineering Pty, Ltd. · Nov 2024
Revitalair 430+
K220290 · Us Hyperbaric Network · May 2023
Revitalair 430F
K171899 · Oxavita Srl · Nov 2019
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
K152223 · Oxyheal Medical Systems, Inc. · Apr 2016
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K140559 · Sechrist Industries, Inc. · May 2014
RSI 4200
K102831 · Reimers Systems, Inc. · Aug 2011