EPIFLO-28
FDA 510(k) K190742 · Neogenix, LLC Dba Ogenix
510(k) numberK190742
Submission
- Device name
- EPIFLO-28
- Applicant
- Neogenix, LLC Dba Ogenix
Beachwood, OH, US - Received
- March 22, 2019
- Decision date
- December 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPJ – Chamber, Oxygen, Topical, Extremity
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5650
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200)KPJ · Special | Vaporox, Inc. | 03/10/2025SE |
| K212121 | VHT-200 Wound Treatment SystemKPJ · Traditional | Vaporox, Inc. | 03/23/2023SE |
| K112634 | Natrox Topical Oxygen Delivery System with IodpKPJ · Traditional | Inotec Amd , Ltd. | 07/03/2012SE |
| K120764 | Epiflo(R)KPJ · Special | Neogenix, LLC | 04/27/2012SE |
| K090681 | Tanscu O2KPJ · Abbreviated | Electrochemical Oxygen Concepts, Inc. | 08/12/2009SE |
| K080966 | Hyper-Box Topical Wound Oxygen SystemKPJ · Traditional | Aoti , Ltd. | 08/06/2008SE |
| K050156 | WHS-1000 Wound Healing SystemKPJ · Traditional | Iyia Technologies, Inc. | 06/17/2005SE |
| K023456 | Oxybox SystemKPJ · Traditional | Oxyfast Corporation | 02/24/2003SE |
| K022028 | VX-400 Topical Hyperbaric Oxygen ChamberKPJ · Traditional | Vascular One, Inc. | 12/17/2002SE |
| K020466 | Hec 1000KPJ · Traditional | Metro Medical Equipment, Inc. | 05/08/2002SE |
Questions and answers
When was EPIFLO-28 cleared by the FDA?
EPIFLO-28 (K190742) received a 510(k) decision of Substantially Equivalent on December 13, 2019, 266 days after the submission was received.
What is the product code of K190742?
The FDA product code is KPJ – Chamber, Oxygen, Topical, Extremity, a Class II (moderate risk) device regulated under 21 CFR 878.5650.