510(k) · Cleared
Recalled · 2012Oxybox System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxyfast Corporation · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Feb 24, 2003 as substantially equivalent to K971507 (Gwr Medical, Llp, 1997) after a 132-day review. Its family tree reaches back 2 generations to 1983. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 24, 2003
- Review
- 132 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K831825 (1983). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK831825 Dispos. Hyperbaric Oxygen Cush/TraumHospitak, Inc. · 1983
- 1 generation backK971507 O2 BOOTGwr Medical, Llp · 1997
- This deviceK023456 Oxybox SystemOxyfast Corporation · 2003
- Descendant · cites it directly · 1 of its ownK120764 Epiflo (R)Neogenix, LLC · 2012
- Descendant · cites it directly · 1 of its ownK090681 Tanscu O2Electrochemical Oxygen Concepts, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK190742 Epiflo-28Neogenix, LLC Dba Ogenix · 2019
- Descendant · cites it directly · 0 of its ownK112634 Natrox Topical Oxygen Delivery System with IodpInotec Amd, Ltd. · 2012
Most influential descendants
Showing 4 of 4 · See all- K120764Epiflo (R)Neogenix, LLC · 2012 · cites it directly1descendant
- K090681Tanscu O2Electrochemical Oxygen Concepts, Inc. · 2009 · cites it directly1descendant
- K190742Epiflo-28Neogenix, LLC Dba Ogenix · 2019 · 2 generations on0descendants
- K112634Natrox Topical Oxygen Delivery System with IodpInotec Amd, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831825 | Dispos. Hyperbaric Oxygen Cush/Traum | Hospitak, Inc. | 1983 | — |
| −1 | K971507 | O2 BOOT | Gwr Medical, Llp | 1997 | — |
| 0 (this device) | K023456 | Oxybox System | Oxyfast Corporation | 2003 | — |
| +1 | K120764 | Epiflo (R) | Neogenix, LLC | 2012 | — |
| +1 | K090681 | Tanscu O2 | Electrochemical Oxygen Concepts, Inc. | 2009 | — |
| +2 | K190742 | Epiflo-28 | Neogenix, LLC Dba Ogenix | 2019 | — |
| +1 | K112634 | Natrox Topical Oxygen Delivery System with Iodp | Inotec Amd, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K971507 | O2 BOOTSummary page 1…Topical oxygen bandage Classification Name: Topical oxygen chamber CFR878.5650, Class I11 3. DEVICES PREDJCATE 0&00t? K971507 4. DEVICE DESCRIPTION OxyBox is a topical bandage system that incorporates a disposable oxygen conce… | 1997 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2012 | Not classified | Z-1477-2012 | Labeling mix-ups | Ogenix Initiated a voluntary recall for the EPIFLO-15 devices due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May 2013 as the expiry date. |
| Mar 24, 2006 | Not classified | Z-1526-06 | Other | Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K120764 (Neogenix, LLC, 2012) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K971507.
How does its category compare?
All KPJ devicesKPJ Chamber, Oxygen, Topical, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 OxyBox System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitis ulcers, 3) amputation/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023456 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023456: Oxybox System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023456
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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