KPJ — Chamber, Oxygen, Topical, Extremity Class II
FDA product code KPJ covers "Chamber, Oxygen, Topical, Extremity", a Class II medical device regulated under 21 CFR 878.5650. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPJ
- Device Class
- Class II
- Regulation Number
- 878.5650
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250188 | Vaporox | Wound Treatment System (VHT-200) | Mar 10, 2025 |
| K212121 | Vaporox | VHT-200 Wound Treatment System | Mar 23, 2023 |
| K190742 | Neogenix, Llc Dba Ogenix | EPIFLO-28 | Dec 13, 2019 |
| K112634 | Inotec Amd | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | Jul 3, 2012 |
| K120764 | Neogenix | EPIFLO(R) | Apr 27, 2012 |
| K090681 | Electrochemical Oxygen Concepts | TANSCU O2 | Aug 12, 2009 |
| K080966 | Aoti | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aug 6, 2008 |
| K050156 | Iyia Technologies | WHS-1000 WOUND HEALING SYSTEM | Jun 17, 2005 |
| K023456 | Oxyfast Corporation | OXYBOX SYSTEM | Feb 24, 2003 |
| K022028 | Vascular One | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | Dec 17, 2002 |
| K020466 | Metro Medical Equipment | HEC 1000 | May 8, 2002 |
| K002632 | Adjunctive Therapeutics | OXYGENATOR | Oct 25, 2001 |
| K981949 | Numotech | NUMOBAG | Feb 3, 1999 |
| K971507 | Gwr Medical | O2 BOOT | Nov 7, 1997 |
| K960756 | Lifetech Systems | LIFETECH CASSETTE | Aug 29, 1997 |
| K963777 | Stephenson Industries | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 | Jul 28, 1997 |
| K920948 | Topox Therapeuutic Rentals | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | Aug 11, 1992 |
| K883848 | Knight Medical | KMI OXY-BAN | Mar 2, 1989 |
| K882461 | Ballard Medical Products | O2 CARE | Nov 28, 1988 |
| K861593 | Stephenson Industries | TOPICAL HYPERBARIC OXYGEN CHAMBER | May 12, 1986 |