Product code KPJ
- Device name
- Chamber, Oxygen, Topical, Extremity
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5650
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | 2025-03-10 |
| K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023-03-23 |
| K190742 | EPIFLO-28 | Neogenix, LLC Dba Ogenix | 2019-12-13 |
| K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | Inotec Amd , Ltd. | 2012-07-03 |
| K120764 | EPIFLO(R) | Neogenix, LLC | 2012-04-27 |
| K090681 | TANSCU O2 | Electrochemical Oxygen Concepts, Inc. | 2009-08-12 |
| K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aoti , Ltd. | 2008-08-06 |
| K050156 | WHS-1000 WOUND HEALING SYSTEM | Iyia Technologies, Inc. | 2005-06-17 |
| K023456 | OXYBOX SYSTEM | Oxyfast Corporation | 2003-02-24 |
| K022028 | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | Vascular One, Inc. | 2002-12-17 |
| K020466 | HEC 1000 | Metro Medical Equipment, Inc. | 2002-05-08 |
| K002632 | OXYGENATOR | Adjunctive Therapeutics, Inc. | 2001-10-25 |
| K981949 | NUMOBAG | Numotech, Inc. | 1999-02-03 |
| K971507 | O2 BOOT | Gwr Medical, Llp | 1997-11-07 |
| K960756 | LIFETECH CASSETTE | Lifetech Systems, Inc. | 1997-08-29 |
| K963777 | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 | Stephenson Industries, Inc. | 1997-07-28 |
| K920948 | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | Topox Therapeuutic Rentals, Inc. | 1992-08-11 |
| K883848 | KMI OXY-BAN | Knight Medical, Inc. | 1989-03-02 |
| K882461 | O2 CARE | Ballard Medical Products | 1988-11-28 |
| K861593 | TOPICAL HYPERBARIC OXYGEN CHAMBER | Stephenson Industries, Inc. | 1986-05-12 |
| K861101 | THE NEW FLEXIBLE COLLAPSIBLE CHAMBER | Stephenson Industries, Inc. | 1986-05-06 |
| K840817 | DISPOSABLE, HYPERBARIC OXYGEN CHAMBER | Hospitak, Inc. | 1984-04-25 |
| K831825 | DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM | Hospitak, Inc. | 1983-10-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060371000356 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2025-12-12 |
| 05060371000370 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2025-12-12 |
| 00851404004121 | OxySpur® lite Oxygen Diffusion Dressings | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004114 | OxyGeni® Oxygen Delivery Extension Set | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004107 | OxySpur® lite Oxygen Diffusion Dressing | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004091 | OxySpur® Oxygen Diffusion Dressing | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004084 | OxyGeni® | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004015 | OxySpur® Oxygen Diffusion Dressing | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004022 | OxySpur® Oxygen Diffusion Dressing | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004039 | OxySpur® Oxygen Diffusion Dressing | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004046 | OxySpur® Oxygen Diffusion Dressing | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004060 | OxyGeni® Humidicant Pack | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00851404004077 | OxyGeni® Dual Port cannula | Electrochemical Oxygen Concepts, Inc. | 2023-07-24 |
| 00860010630600 | Numobag Kit | Numotech, Inc. | 2023-07-11 |
| 00855526003079 | EPIFLO® | Ogenix | 2023-06-08 |
| 00855526003086 | EPIFLO® | Ogenix | 2023-06-08 |
| 05060371000387 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2022-03-08 |
| 05060371000349 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2020-07-20 |
| 05060371000363 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2020-07-20 |
| 05060371000288 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2019-06-06 |
| 05060371000325 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2019-06-06 |
| 05060371000172 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2019-03-01 |
| 05060371000165 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2019-03-01 |
| 05060371000004 | NATROX® Oxygen Wound Therapy | INOTEC AMD LIMITED | 2018-10-05 |
| 05391518740027 | Hyperbox System | AOTI LIMITED | 2017-07-17 |
| 53915187400272 | Hyperbox System | AOTI LIMITED | 2017-07-17 |
| 05391518749990 | Hyperbox System | AOTI LIMITED | 2017-07-05 |
| 53915187499900 | Hyperbox System | AOTI LIMITED | 2017-07-05 |
| 00855526003055 | EPIFLO® | Ogenix | 2016-10-07 |
| 00026072011263 | Allied Medical LLC | Allied Medical, LLC | 2016-09-16 |