Chamber, Hyperbaric
FDA product code CBF · Class II (moderate risk) · 21 CFR 868.5470 · Anesthesiology
69510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Sechrist Industries, Inc. 5
- Reimers Systems, Inc. 5
- Environmental Tectonics Corp. 3
- Perry Baromedical Corp. 3
- Perry Baromedical Services 3
- Pan-America Hyperbarics, Inc. 3
- Gulf Coast Hyperbarics, Inc. 3
- Nautilus Environmedical Systems, Inc. 2
- Hyperbaric Technologies, Inc. 2
- Oxyheal Medical Systems, Inc. 2
- Tampa Hyperbaric Ent. 2
- Hypertec, Inc. 2
- Khrunichev State Research & Production Space Centr 2
- Fink Engineering Pty, Ltd. 2
- Migada, Ltd. 1
- Hyperbaric Aerobics, Ltd. 1
- Hyox Systems C/O Mechidyne Systems, Inc. 1
- Us Hyperbaric Network 1
- Biochem International, Inc. 1
- Custom Craft Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberCBF · Traditional | Fink Engineering Pty, Ltd. | 11/21/2024SE |
| K220290 | Revitalair 430+CBF · Traditional | Us Hyperbaric Network | 05/04/2023SE |
| K171899 | Revitalair 430FCBF · Traditional | Oxavita Srl | 11/22/2019SE |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyCBF · Special | Oxyheal Medical Systems, Inc. | 03/22/2017SE |
| K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…CBF · Traditional | Oxyheal Medical Systems, Inc. | 04/29/2016SE |
| K140559 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 05/30/2014SE |
| K102831 | Rsi 4200CBF · Abbreviated | Reimers Systems, Inc. | 08/19/2011SE |
| K092991 | O.S.C.A.R. (Operating System for Control and Record Keeping)CBF · Traditional | Environmental Tectonics Corp. | 08/13/2010SE |
| K101262 | Flexi-LiteCBF · Traditional | Pressure-Tech, Inc. | 06/10/2010SE |
| K100268 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 04/26/2010SE |
| K082455 | Rectangular Multiplace Hyperbaric ChamberCBF · Traditional | Gulf Coast Hyperbarics, Inc. | 05/22/2009SE |
| K081506 | Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsCBF · Abbreviated | Hyperbaric America, LLC | 07/25/2008SE |
| K072427 | Sigma Series Hyperbaric ChamberCBF · Abbreviated | Perry Baromedical Corp. | 06/11/2008SE |
| K072757 | Dive and Shallow and Grand DiveCBF · Traditional | Summit TO Sea | 02/08/2008SE |
| K060739 | Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307CBF · Special | Khrunichev State Research & Production Space Centr | 07/21/2006SE |
| K053498 | Hyperox 101CBF · Traditional | Wjo, Inc. | 03/15/2006SE |
| K052866 | Oxyheal 1000 Monoplace Hyperbaric ChamberCBF · Abbreviated | Oxyheal Health Group | 12/13/2005SE |
| K051759 | Flexi-Lite, Model FL-V1.2CBF · Traditional | Performance Hyperbarics | 11/17/2005SE |
| K052713 | Model 3300E/ER Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 10/28/2005SE |
| K040145 | Ata HCM Monoplace Hyperbaric SystemCBF · Traditional | Ata Hyperbaric Chamber Manufacturing | 05/04/2005SE |
| K041007 | Millenium, Models 2000, 2001 and 2002CBF · Traditional | Hyperbaric For Life, LLC | 11/15/2004SE |
| K030418 | Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemCBF · Traditional | Makai Marine Industries, Inc. | 01/29/2004SE |
| K030713 | Bay Area HypersciencesCBF · Abbreviated | Bay Area Hypersciences, LLC | 12/19/2003SE |
| K031649 | SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesCBF · Abbreviated | Fink Engineering Pty, Ltd. | 12/05/2003SE |
| K022214 | Msi I2010 Dual Place Hyperbaric ChamberCBF · Traditional | Mechidyne Systems, Inc. | 02/26/2003SE |
| K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model PAH-S1CBF · Abbreviated | Pan-America Hyperbarics, Inc. | 10/24/2002SE |
| K021690 | Pan-America Hyperbarics Hyperbaric Chamber System, Model PAH-M3+1CBF · Abbreviated | Pan-America Hyperbarics, Inc. | 10/24/2002SE |
| K021689 | Pan-America Hyperbarics, Hyperbaric Chamber System, Model PAH-M10+2CBF · Abbreviated | Pan-America Hyperbarics, Inc. | 10/24/2002SE |
| K020974 | Bara-Med Acrylic Monoplace Hyperbaric ChamberCBF · Traditional | Environmental Tectonics Corp. | 06/26/2002SESU |
| K011592 | Oxygen Treatment HoodCBF · Traditional | Amron International Diving Supply, Inc. | 06/19/2002SE |
| K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesCBF · Abbreviated | Hyperbaric Technologies, Inc. | 06/06/2002SE |
| K001121 | Oxygen Applied Symptom Improvement System (Oasis)CBF · Abbreviated | Engineered Medical Technology, Inc. | 11/29/2001SE |
| K011565 | Infant Oxygen Treatment HoodCBF · Traditional | Gulf Coast Hyperbarics, Inc. | 08/16/2001SE |
| K011312 | BLKS-303 MK Monoplace Hyperbaric SystemCBF · Abbreviated | Khrunichev State Research & Production Space Centr | 07/18/2001SE |
| K010659 | Sea-Long Medical Treatment HoodCBF · Special | Sea-Long Medical Systems, Inc. | 05/16/2001SE |
| K002795 | Model Hybrid 3200 Monoplace, Hyperbaric Therapy SystemsCBF · Traditional | Hypertec, Inc. | 12/06/2000SE |
| K002794 | Model 5000 Multiplace Hyperbaric TherapyCBF · Traditional | Hypertec, Inc. | 12/06/2000SE |
| K001409 | Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-CizerCBF · Traditional | Hyperbaric Technologies, Inc. | 08/02/2000SE |
| K993010 | Bara-Med, Acrylic Monoplace Hyperbaric ChamberCBF · Traditional | Environmental Tectonics Corp. | 05/30/2000SE |
| K990927 | Sigma 3400 Monoplace Hyperbaric ChamberCBF · Traditional | Perry Baromedical Corp. | 11/12/1999SE |
| K984313 | HTU3CBF · Traditional | Hyox Systems , Ltd. | 10/22/1999SE |
| K981938 | Tampa Hyperbaric Monoplace ChamberCBF · Traditional | Tampa Hyperbaric Ent. | 07/06/1999SE |
| K983648 | Sigma Plus/ II Multiplace Hyperbaric SystemCBF · Traditional | Perry Baromedical Services | 02/24/1999SE |
| K972908 | Sands Series III Hyperbaric ChamberCBF · Traditional | Sands Hyperbarics | 07/22/1998SE |
| K974868 | Sigma Plus Monoplace Hyperbaric ChamberCBF · Traditional | Perry Baromedical Corp. | 07/02/1998SE |
| K952545 | Wright 1000 Monoplace Hyperbaric SystemCBF · Traditional | Wright Industries | 05/28/1997SE |
| K960389 | Hyperbaric ChamberCBF · Traditional | Tampa Hyperbaric Ent. | 12/05/1996SE |
| K962871 | ODS1 - Hood DriverCBF · Traditional | Reimers Systems, Inc. | 10/23/1996SE |
| K962869 | GSP1 - Gas Selection PanelCBF · Traditional | Reimers Systems, Inc. | 10/23/1996SE |
| K955535 | Louisville Labs Oxygen Head TentCBF · Traditional | Louisville Laboratories, Inc. | 07/01/1996SE |
| K951044 | System One Hyperbaric ChamberCBF · Traditional | Nth Systems, Inc. | 01/25/1996SE |
| K954387 | T Class Hyperbaric FacilitiesCBF · Traditional | Reimers Systems, Inc. | 12/15/1995SE |
| K950386 | Model 3200P/3200PR Hyperbaric ChamberCBF · Traditional | Sechrist Industries, Inc. | 06/13/1995SE |
| K934164 | Model 2500E/2500ER Hyperbaric ChamberCBF · Traditional | Sechrist Industries, Inc. | 06/13/1995SE |
| K951125 | Lifeforce Clinical Hyperbaric FacilityCBF · Traditional | Reimers Systems, Inc. | 06/02/1995SE |
| K950957 | Multiplace Hyperbaric Treatment Chamber SystemCBF · Traditional | Gulf Coast Hyperbarics, Inc. | 06/02/1995SE |
| K933929 | Lab-Site(R) Safety CannulaCBF · Traditional | Migada, Ltd. | 12/07/1993SE |
| K930748 | Sigma MP Multiplace Hyperbaric ChamberCBF · Traditional | Perry Baromedical Services | 08/20/1993SE |
| K905168 | HyperliteCBF · Traditional | S.O.S. , Ltd. | 07/22/1991SE |
| K874752 | Gamow Hyperbaric BagCBF · Traditional | Hyperbaric Aerobics, Ltd. | 02/02/1988SE |
| K874107 | H.T.U. (Hyperbaric Therapy Unit)CBF · Traditional | Hyox Systems C/O Mechidyne Systems, Inc. | 12/07/1987SE |
| K862198 | Sigma II - Dual Place Hyperbaric ChamberCBF · Traditional | Perry Baromedical Services | 11/12/1986SE |
| K861315 | Hyperbaric Penetration Extension SetCBF · Traditional | Cutter Laboratories, Inc. | 05/21/1986SE |
| K850563 | Sechrist Ventilator/Nautilus Chamber CombinationCBF · Traditional | Nautilus Environmedical Systems, Inc. | 03/12/1985SE |
| K842303 | Microspan -Ph MonitorCBF · Traditional | Biochem International, Inc. | 10/12/1984SE |
| K840841 | Reneau UnitCBF · Traditional | Reneau, Inc. | 08/07/1984SE |
| K841608 | Model 3000 Hyperbaric ChamberCBF · Traditional | Custom Craft Products, Inc. | 05/02/1984SE |
| K832127 | Nautilus Monoplace Hyperbaric UnitCBF · Traditional | Nautilus Environmedical Systems, Inc. | 08/12/1983SE |
| K790693 | Hyperbaric Oxygen ChamberCBF · Traditional | Hyperbaric Oxygen Therapy, Inc. | 07/30/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2734-2014 Class II | The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated…The firm is distributing the Rejuvenator device without an approved 510(k). | Baro-Therapies, Inc | 08/08/2014Terminated |
| Z-0209-2013 Class II | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The…Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in… | Sechrist Industries Inc | 08/28/2008Terminated |
| Z-0208-2013 Class II | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The…Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in… | Sechrist Industries Inc | 08/28/2008Terminated |