510(k) · Cleared
ClearedVX-400 Topical Hyperbaric Oxygen Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular One, Inc. · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Dec 17, 2002 as substantially equivalent to K971507 (Gwr Medical, Llp, 1997) and 1 other predicate after a 179-day review. Its family tree reaches back 2 generations to 1983. 4 later devices descend from it.
- Decided
- Dec 17, 2002
- Review
- 179 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K831825 (1983). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK831825 Dispos. Hyperbaric Oxygen Cush/TraumHospitak, Inc. · 1983
- 1 generation backK971507 O2 BOOTGwr Medical, Llp · 1997
- This deviceK022028 VX-400 Topical Hyperbaric Oxygen ChamberVascular One, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK080966 Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK212121 VHT-200 Wound Treatment SystemVaporox, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK250188 Wound Treatment System (VHT-200)Vaporox, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK050156 WHS-1000 Wound Healing SystemIyia Technologies, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K080966Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008 · cites it directly2descendants
- K212121VHT-200 Wound Treatment SystemVaporox, Inc. · 2023 · 2 generations on1descendant
- K250188Wound Treatment System (VHT-200)Vaporox, Inc. · 2025 · 3 generations on0descendants
- K050156WHS-1000 Wound Healing SystemIyia Technologies, Inc. · 2005 · 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) | K022028 | VX-400 Topical Hyperbaric Oxygen Chamber | Vascular One, Inc. | 2002 | — |
| +1 | K080966 | Hyper-Box Topical Wound Oxygen System | Aoti, Ltd. | 2008 | — |
| +2 | K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023 | — |
| +3 | K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | 2025 | — |
| +1 | K050156 | WHS-1000 Wound Healing System | Iyia Technologies, Inc. | 2005 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (3)
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…Name of the Device:, VX-400 Topical Hyperbaric Oxygen Chamber 3. Predicate Device Information: 0 2 Boot, GWR Medical, LLP, Chadds Ford, PA, W971507 0 Topox Topical Sacral Hyperbaric Oxygen Chamber, Topox, Inc. North Attleboro, MA, W920948 The Topical H… | 1997 |
| * | K920948 | Topical Sacral Hyperbaric Oxygen ChamberSummary page 1…ation: 0 2 Boot, GWR Medical, LLP, Chadds Ford, PA, W971507 0 Topox Topical Sacral Hyperbaric Oxygen Chamber, Topox, Inc. North Attleboro, MA, W920948 The Topical Hyperbaric Oxygen Extremity Chamber, Advanced Hyberbaric Technologies, Inc., Farmingdale, NJ. (Gran… | 1992 |
| * | — | Topical Hyperbaric Oxygen Extremity Chamber Named without a submission number |
What descends from it? (4)
2 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)
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 19 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, K080966 (Aoti, Ltd., 2008) has gone furthest, with 2 descendants 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?
For Treatmeni: of open acute or chronic wounds, e.g.,
Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions
Decubitus ulcers
Amputations/infected stumps
Skin grafts
Burns
Frostbite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022028: VX-400 Topical Hyperbaric Oxygen Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022028
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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