CBF · Chamber, Hyperbaric
Anesthesiology · 21 CFR 868.5470 · Class 2
Overview
| Product Code | CBF |
|---|---|
| Device Name | Chamber, Hyperbaric |
| Regulation | 21 CFR 868.5470 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty, Ltd. | Nov 21, 2024 | SESE |
| K220290 | Revitalair 430+ | Us Hyperbaric Network | May 4, 2023 | SESE |
| K171899 | Revitalair 430F | Oxavita Srl | Nov 22, 2019 | SESE |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | Oxyheal Medical Systems, Inc. | Mar 22, 2017 | SESE |
| K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System | Oxyheal Medical Systems, Inc. | Apr 29, 2016 | SESE |
| K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | May 30, 2014 | SESE |
| K102831 | RSI 4200 | Reimers Systems, Inc. | Aug 19, 2011 | SESE |
| K092991 | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) | Environmental Tectonics Corp. | Aug 13, 2010 | SESE |
| K101262 | FLEXI-LITE | Pressure-Tech, Inc. | Jun 10, 2010 | SESE |
| K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | Apr 26, 2010 | SESE |
| K082455 | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER | Gulf Coast Hyperbarics, Inc. | May 22, 2009 | SESE |
| K081506 | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS | Hyperbaric America, LLC | Jul 25, 2008 | SESE |
| K072427 | SIGMA SERIES HYPERBARIC CHAMBER | Perry Baromedical Corp. | Jun 11, 2008 | SESE |
| K072757 | DIVE AND SHALLOW AND GRAND DIVE | Summit TO Sea | Feb 8, 2008 | SESE |
| K060739 | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 | Khrunichev State Research & Production Space Centr | Jul 21, 2006 | SESE |
| K053498 | HYPEROX 101 | Wjo, Inc. | Mar 15, 2006 | SESE |
| K052866 | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER | Oxyheal Health Group | Dec 13, 2005 | SESE |
| K051759 | FLEXI-LITE, MODEL FL-V1.2 | Performance Hyperbarics | Nov 17, 2005 | SESE |
| K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | Oct 28, 2005 | SESE |
| K040145 | 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
