FDA Product Code
FDA Product Code KPJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5650
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | 2025-03-10 | Special | PDF ↗ |
| K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023-03-23 | Traditional | PDF ↗ |
| K190742 | EPIFLO-28 | Neogenix, LLC Dba Ogenix | 2019-12-13 | Traditional | PDF ↗ |
| K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | Inotec Amd , Ltd. | 2012-07-03 | Traditional | PDF ↗ |
| K120764 | EPIFLO(R) | Neogenix, LLC | 2012-04-27 | Special | PDF ↗ |
| K090681 | TANSCU O2 | Electrochemical Oxygen Concepts, Inc. | 2009-08-12 | Abbreviated | PDF ↗ |
| K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aoti , Ltd. | 2008-08-06 | Traditional | PDF ↗ |
| K050156 | WHS-1000 WOUND HEALING SYSTEM | Iyia Technologies, Inc. | 2005-06-17 | Traditional | PDF ↗ |
| K023456 | OXYBOX SYSTEM | Oxyfast Corporation | 2003-02-24 | Traditional | PDF ↗ |
| K022028 | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | Vascular One, Inc. | 2002-12-17 | Traditional | PDF ↗ |
| K020466 | HEC 1000 | Metro Medical Equipment, Inc. | 2002-05-08 | Traditional | PDF ↗ |
| K002632 | OXYGENATOR | Adjunctive Therapeutics, Inc. | 2001-10-25 | Traditional | PDF ↗ |
| K981949 | NUMOBAG | Numotech, Inc. | 1999-02-03 | Traditional | PDF ↗ |
| K971507 | O2 BOOT | Gwr Medical, Llp | 1997-11-07 | Traditional | PDF ↗ |
| K960756 | LIFETECH CASSETTE | Lifetech Systems, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K963777 | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 | Stephenson Industries, Inc. | 1997-07-28 | Traditional | PDF ↗ |
| K920948 | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | Topox Therapeuutic Rentals, Inc. | 1992-08-11 | Traditional | PDF ↗ |
| K883848 | KMI OXY-BAN | Knight Medical, Inc. | 1989-03-02 | Traditional | PDF ↗ |
| K882461 | O2 CARE | Ballard Medical Products | 1988-11-28 | Traditional | PDF ↗ |
| K861593 | TOPICAL HYPERBARIC OXYGEN CHAMBER | Stephenson Industries, Inc. | 1986-05-12 | Traditional | PDF ↗ |
| K861101 | THE NEW FLEXIBLE COLLAPSIBLE CHAMBER | Stephenson Industries, Inc. | 1986-05-06 | Traditional | PDF ↗ |
| K840817 | DISPOSABLE, HYPERBARIC OXYGEN CHAMBER | Hospitak, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K831825 | DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM | Hospitak, Inc. | 1983-10-27 | Traditional | PDF ↗ |
Product code KPJ · Class II · General, Plastic Surgery. Data: openFDA.