510(k) · Cleared
ClearedWound Treatment System (VHT-200)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vaporox, Inc. · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Mar 10, 2025 as substantially equivalent to K212121 (Vaporox, Inc., 2023) after a 47-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Mar 10, 2025
- Review
- 47 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K831825 (1983). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK831825 Dispos. Hyperbaric Oxygen Cush/TraumHospitak, Inc. · 1983
- 4 generations backK971507 O2 BOOTGwr Medical, Llp · 1997
- 3 generations backK022028 VX-400 Topical Hyperbaric Oxygen ChamberVascular One, Inc. · 2002
- 2 generations backK080966 Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008
- 1 generation backK212121 VHT-200 Wound Treatment SystemVaporox, Inc. · 2023
- This deviceK250188 Wound Treatment System (VHT-200)Vaporox, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K831825 | Dispos. Hyperbaric Oxygen Cush/Traum | Hospitak, Inc. | 1983 | — |
| −4 | K971507 | O2 BOOT | Gwr Medical, Llp | 1997 | — |
| −3 | K022028 | VX-400 Topical Hyperbaric Oxygen Chamber | Vascular One, Inc. | 2002 | — |
| −2 | K080966 | Hyper-Box Topical Wound Oxygen System | Aoti, Ltd. | 2008 | — |
| −1 | K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 K212121 VHT-200 Wound Treatment Systemscore 9.0 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K212121 | VHT-200 Wound Treatment SystemSummary page 5…PRODUCT CODE: KPJ REVIEW PANEL: General & Plastic Surgery PREDICATE DEVICE: VHT-200 Wound Treatment System (K212121) DEVICE DESCRIPTION: The VHT-200 Wound Treatment System (VHT-200) is a prescription medical device. This system is designed for… | 2023 |
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 42 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All KPJ devicesKPJ Chamber, Oxygen, Topical, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
VHT-200 is intended to provide ultrasonically generated mist and concentrated oxygen to open, acute and chronic wounds as an adjunct therapy in wound management and treatment.
The VHT-200 is intended for the following kinds of wounds:
• Skin ulcerations due to diabetes, venous stasis, and post-surgical infections
• Gangrenous lesions
• Decubitus ulcers
• Amputations / infected stumps
• Skin grafts
• Burns
• Frostbite
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250188 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250188: Wound Treatment System (VHT-200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250188
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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