510(k) · Cleared
ClearedEpiflo-28
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neogenix, LLC Dba Ogenix · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Dec 13, 2019 as substantially equivalent to K120764 (Neogenix, LLC, 2012) after a 266-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Dec 13, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K831825 (1983). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK831825 Dispos. Hyperbaric Oxygen Cush/TraumHospitak, Inc. · 1983
- 3 generations backK971507 O2 BOOTGwr Medical, Llp · 1997
- 2 generations backK023456 Oxybox SystemOxyfast Corporation · 2003 · Recalled
- 1 generation backK120764 Epiflo (R)Neogenix, LLC · 2012
- This deviceK190742 Epiflo-28Neogenix, LLC Dba Ogenix · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831825 | Dispos. Hyperbaric Oxygen Cush/Traum | Hospitak, Inc. | 1983 | — |
| −3 | K971507 | O2 BOOT | Gwr Medical, Llp | 1997 | — |
| −2 | K023456 | Oxybox System | Oxyfast Corporation | 2003 | 2 |
| −1 | K120764 | Epiflo (R) | Neogenix, LLC | 2012 | — |
| 0 (this device) | K190742 | Epiflo-28 | Neogenix, LLC Dba Ogenix | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPJ device
- #1 K250188 Wound Treatment System (VHT-200)score 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120764 | Epiflo (R)Summary page 4…21 CFR 878.5650 – Class II (Special Controls) Product Code: KPJ 3. PREDICATE DEVICES EPIFLO System – K120764 4. DEVICE DESCRIPTION EPIFLO-28 is an oxygen delivery device that incorporates a disposable oxygen concentrator. It c… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All KPJ devicesKPJ Chamber, Oxygen, Topical, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KPJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPJ
Too few KPJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KPJ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPJ
No MAUDE report names KPJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190742: Epiflo-28.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190742
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026