Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5470](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5470) → CBF — Chamber, Hyperbaric # CBF · Chamber, Hyperbaric _Anesthesiology · 21 CFR 868.5470 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF ## Overview - **Product Code:** CBF - **Device Name:** Chamber, Hyperbaric - **Regulation:** [21 CFR 868.5470](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5470) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes - **Life-sustaining:** yes ## Identification A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650). ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 69) Showing 20 most recent of 69 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K240569](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K240569.md) | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty, Ltd. | Nov 21, 2024 | SESE | | [K220290](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K220290.md) | Revitalair 430+ | Us Hyperbaric Network | May 4, 2023 | SESE | | [K171899](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K171899.md) | Revitalair 430F | Oxavita Srl | Nov 22, 2019 | SESE | | [K163109](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K163109.md) | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | Oxyheal Medical Systems, Inc. | Mar 22, 2017 | SESE | | [K152223](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K152223.md) | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System | Oxyheal Medical Systems, Inc. | Apr 29, 2016 | SESE | | [K140559](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K140559.md) | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | May 30, 2014 | SESE | | [K102831](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K102831.md) | RSI 4200 | Reimers Systems, Inc. | Aug 19, 2011 | SESE | | [K092991](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K092991.md) | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) | Environmental Tectonics Corp. | Aug 13, 2010 | SESE | | [K101262](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K101262.md) | FLEXI-LITE | Pressure-Tech, Inc. | Jun 10, 2010 | SESE | | [K100268](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K100268.md) | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | Apr 26, 2010 | SESE | | [K082455](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K082455.md) | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER | Gulf Coast Hyperbarics, Inc. | May 22, 2009 | SESE | | [K081506](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K081506.md) | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS | Hyperbaric America, LLC | Jul 25, 2008 | SESE | | [K072427](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K072427.md) | SIGMA SERIES HYPERBARIC CHAMBER | Perry Baromedical Corp. | Jun 11, 2008 | SESE | | [K072757](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K072757.md) | DIVE AND SHALLOW AND GRAND DIVE | Summit TO Sea | Feb 8, 2008 | SESE | | [K060739](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K060739.md) | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 | Khrunichev State Research & Production Space Centr | Jul 21, 2006 | SESE | | [K053498](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K053498.md) | HYPEROX 101 | Wjo, Inc. | Mar 15, 2006 | SESE | | [K052866](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K052866.md) | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER | Oxyheal Health Group | Dec 13, 2005 | SESE | | [K051759](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K051759.md) | FLEXI-LITE, MODEL FL-V1.2 | Performance Hyperbarics | Nov 17, 2005 | SESE | | [K052713](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K052713.md) | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | Oct 28, 2005 | SESE | | [K040145](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF/K040145.md) | ATA HCM MONOPLACE HYPERBARIC SYSTEM | Ata Hyperbaric Chamber Manufacturing | May 4, 2005 | SESE | ## Top Applicants - Reimers Systems, Inc. — 5 clearances - Sechrist Industries, Inc. — 5 clearances - Environmental Tectonics Corp. — 3 clearances - Gulf Coast Hyperbarics, Inc. — 3 clearances - Pan-America Hyperbarics, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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