Product code CBF
- Device name
- Chamber, Hyperbaric
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5470
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty, Ltd. | 2024-11-21 |
| K220290 | Revitalair 430+ | Us Hyperbaric Network | 2023-05-04 |
| K171899 | Revitalair 430F | Oxavita Srl | 2019-11-22 |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | Oxyheal Medical Systems, Inc. | 2017-03-22 |
| K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System | Oxyheal Medical Systems, Inc. | 2016-04-29 |
| K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | 2014-05-30 |
| K102831 | RSI 4200 | Reimers Systems, Inc. | 2011-08-19 |
| K092991 | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) | Environmental Tectonics Corp. | 2010-08-13 |
| K101262 | FLEXI-LITE | Pressure-Tech, Inc. | 2010-06-10 |
| K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | 2010-04-26 |
| K082455 | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER | Gulf Coast Hyperbarics, Inc. | 2009-05-22 |
| K081506 | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS | Hyperbaric America, LLC | 2008-07-25 |
| K072427 | SIGMA SERIES HYPERBARIC CHAMBER | Perry Baromedical Corp. | 2008-06-11 |
| K072757 | DIVE AND SHALLOW AND GRAND DIVE | Summit TO Sea | 2008-02-08 |
| K060739 | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 | Khrunichev State Research & Production Space Centr | 2006-07-21 |
| K053498 | HYPEROX 101 | Wjo, Inc. | 2006-03-15 |
| K052866 | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER | Oxyheal Health Group | 2005-12-13 |
| K051759 | FLEXI-LITE, MODEL FL-V1.2 | Performance Hyperbarics | 2005-11-17 |
| K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | 2005-10-28 |
| K040145 | ATA HCM MONOPLACE HYPERBARIC SYSTEM | Ata Hyperbaric Chamber Manufacturing | 2005-05-04 |
| K041007 | MILLENIUM, MODELS 2000, 2001 AND 2002 | Hyperbaric For Life, LLC | 2004-11-15 |
| K030418 | MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM | Makai Marine Industries, Inc. | 2004-01-29 |
| K030713 | BAY AREA HYPERSCIENCES | Bay Area Hypersciences, LLC | 2003-12-19 |
| K031649 | SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES | Fink Engineering Pty, Ltd. | 2003-12-05 |
| K022214 | MSI I2010 DUAL PLACE HYPERBARIC CHAMBER | Mechidyne Systems, Inc. | 2003-02-26 |
| K021693 | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1 | Pan-America Hyperbarics, Inc. | 2002-10-24 |
| K021689 | PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 | Pan-America Hyperbarics, Inc. | 2002-10-24 |
| K021690 | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1 | Pan-America Hyperbarics, Inc. | 2002-10-24 |
| K020974 | BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER | Environmental Tectonics Corp. | 2002-06-26 |
| K011592 | OXYGEN TREATMENT HOOD | Amron International Diving Supply, Inc. | 2002-06-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860006478988 | HMS-5000-6-MINI-QUADRO | Hyperbaric Modular Systems Inc. | 2026-05-05 |
| 08906124945116 | TEKNA Manufacturing Pvt. Ltd. | TEKNA MANUFACTURING PRIVATE LIMITED | 2026-04-30 |
| 08906124945123 | TEKNA Manufacturing Pvt. Ltd. | TEKNA MANUFACTURING PRIVATE LIMITED | 2026-04-30 |
| 08906124944713 | TEKNA Manufacturing Pvt. Ltd. | TEKNA MANUFACTURING PRIVATE LIMITED | 2026-02-12 |
| G625R8003410 | Hyperbaric for Life | Hyperbaric For Life.com, Llc | 2025-08-20 |
| 00850011262016 | PCCI Hyperbaric Systems | PCCI HYPERBARIC SYSTEMS | 2025-07-14 |
| 00860006478919 | HMS-5000 | Hyperbaric Modular Systems Inc. | 2025-06-16 |
| G625R800340 | Hyperbaric for Life | Hyperbaric For Life.com, Llc | 2025-06-02 |
| 08906124943068 | TEKNA Manufacturing Pvt. Ltd. | TEKNA MANUFACTURING PRIVATE LIMITED | 2025-05-04 |
| 08906124943051 | TEKNA Manufacturing Pvt. Ltd. | TEKNA MANUFACTURING PRIVATE LIMITED | 2025-05-04 |
| G623430 | US Hyperbaric Network | US Hyperbaric Network LLC | 2025-05-02 |
| 00850052737009 | Sea-Long Medical Hood | Sea-Long Medical Systems LLC | 2024-11-21 |
| 08906124941477 | TEKNA Manufacturing Pvt. Ltd. | TEKNA MANUFACTURING PRIVATE LIMITED | 2024-09-03 |
| 00852834007003 | Newtowne Tent Chamber | TYPHOON WATER WARES LTD | 2024-05-28 |
| B878430F0 | Revitalair | OXAVITA S.R.L. | 2024-01-19 |
| 08906124940012 | TEKNA Manufacturing Pvt. Ltd. | TEKNA MANUFACTURING PRIVATE LIMITED | 2024-01-10 |
| B718TL20287CM090 | Multiplace Hyperbaric Oxygen Treatment Chamber | FINK ENGINEERING PTY LTD | 2019-10-04 |
| B718TL20287CM060 | Multiplace Hyperbaric Oxygen Treatment Chamber | FINK ENGINEERING PTY LTD | 2019-10-04 |
| 00899660002000 | Sechrist Industries, Inc. | SECHRIST INDUSTRIES, INC. | 2017-06-02 |
| 00899660002017 | Sechrist Industries, Inc. | SECHRIST INDUSTRIES, INC. | 2016-12-12 |
| 00899660002024 | Sechrist Industries, Inc. | SECHRIST INDUSTRIES, INC. | 2016-12-12 |
| 10856039006059 | Vitaeris 320 | HYPERBARIC TECHNOLOGIES, INC. | 2016-10-31 |
| 10856039006714 | Quamvis Lite 320 | HYPERBARIC TECHNOLOGIES, INC. | 2016-03-22 |
| 10856039006615 | Quamvis 270 | HYPERBARIC TECHNOLOGIES, INC. | 2016-03-22 |
| 10856039006516 | Gamow Bag | HYPERBARIC TECHNOLOGIES, INC. | 2016-03-22 |
| 10856039006417 | Gamow Ultra-Lite | HYPERBARIC TECHNOLOGIES, INC. | 2016-03-22 |
| 10856039006318 | Quamvis 320 | HYPERBARIC TECHNOLOGIES, INC. | 2016-03-22 |
| 10856039006219 | Solace 210 | HYPERBARIC TECHNOLOGIES, INC. | 2016-03-22 |
| 10856039006110 | Respiro 270 | HYPERBARIC TECHNOLOGIES, INC. | 2016-03-22 |
| 10856039006011 | Vitaeris 320 | HYPERBARIC TECHNOLOGIES, INC. | 2016-03-22 |