# K190742: Epiflo-28

- Pathway: 510(k) (Traditional)
- Applicant: Neogenix, LLC Dba Ogenix
- Decided: Dec 13, 2019 after 266 days
- Product code: KPJ (Chamber, Oxygen, Topical, Extremity)
- Device class: 2
- Regulation: 21 CFR 878.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K831825 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120764: Epiflo (R), Neogenix, LLC (2012) Summary page 4.

## Indications for use
The EPIFLO-28 is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) Pressure ulcers, 3) amputations/infected stumps, 4) Skin grafts, 5) burns, and 6) frostbite

Source page: https://510kreport.com/device/K190742
Methodology: https://510kreport.com/methodology