510(k) · Cleared
ClearedHyper-Box Topical Wound Oxygen System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aoti, Ltd. · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Aug 6, 2008 as substantially equivalent to K022028 (Vascular One, Inc., 2002) and 2 other predicates after a 124-day review. Its family tree reaches back 3 generations to 1983. 2 later devices descend from it.
- Decided
- Aug 6, 2008
- Review
- 124 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K831825 (1983). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK831825 Dispos. Hyperbaric Oxygen Cush/TraumHospitak, Inc. · 1983
- 2 generations backK971507 O2 BOOTGwr Medical, Llp · 1997
- 1 generation backK022028 VX-400 Topical Hyperbaric Oxygen ChamberVascular One, Inc. · 2002
- This deviceK080966 Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK212121 VHT-200 Wound Treatment SystemVaporox, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK250188 Wound Treatment System (VHT-200)Vaporox, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831825 | Dispos. Hyperbaric Oxygen Cush/Traum | Hospitak, Inc. | 1983 | — |
| −2 | K971507 | O2 BOOT | Gwr Medical, Llp | 1997 | — |
| −1 | K022028 | VX-400 Topical Hyperbaric Oxygen Chamber | Vascular One, Inc. | 2002 | — |
| 0 (this device) | K080966 | Hyper-Box Topical Wound Oxygen System | Aoti, Ltd. | 2008 | — |
| +1 | K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023 | — |
| +2 | K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K022028 | VX-400 Topical Hyperbaric Oxygen ChamberSummary page 1…Technologies Inc. Topical Amendment) CFR 878.5650 Hyperbaric Oxygen Extremity Chamber Vascular One, Inc VX-400 K022028 Class III per 21 Topical Hyperbaric Oxygen CFR 878.5650 Chamber… | 2002 |
| * | K971507 | O2 BOOTSummary page 1…Class III per 21 Topical Hyperbaric Oxygen CFR 878.5650 Chamber GWR Medical 02 Boot device K971507 Class III per 21 CFR 878.5650 Metro Medi… | 1997 |
| * | K020466 | HEC 1000Summary page 1…ice K971507 Class III per 21 CFR 878.5650 Metro Medical Manufacturing K020466 Class III per 21 HEC 1000 Topical Oxygen CFR 878.5650 Chamber fo… | 2002 |
| * | — | Advanced Hyperbaric Technologies Inc. Topical Hyperbaric Oxygen Extremity Chamber Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212121 | VHT-200 Wound Treatment System | 2023 | 1 |
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 25 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K212121 (Vaporox, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K022028.
How does its category compare?
All KPJ devicesKPJ Chamber, Oxygen, Topical, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 AOTI Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as;
o skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions
o decubitus ulcers
o amputations/infected stumps
o skin grafts
o bums
o frostbite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080966: Hyper-Box Topical Wound Oxygen System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080966
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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