510(k) · Cleared
ClearedVHT-200 Wound Treatment System
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 23, 2023 as substantially equivalent to K080966 (Aoti, Ltd., 2008) after a 624-day review. Its family tree reaches back 4 generations to 1983. 1 later device descends from it.
- Decided
- Mar 23, 2023
- Review
- 624 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K831825 (1983). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK831825 Dispos. Hyperbaric Oxygen Cush/TraumHospitak, Inc. · 1983
- 3 generations backK971507 O2 BOOTGwr Medical, Llp · 1997
- 2 generations backK022028 VX-400 Topical Hyperbaric Oxygen ChamberVascular One, Inc. · 2002
- 1 generation backK080966 Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008
- This deviceK212121 VHT-200 Wound Treatment SystemVaporox, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250188 Wound Treatment System (VHT-200)Vaporox, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250188Wound Treatment System (VHT-200)Vaporox, Inc. · 2025 · cites it directly0descendants
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 | K022028 | VX-400 Topical Hyperbaric Oxygen Chamber | Vascular One, Inc. | 2002 | — |
| −1 | K080966 | Hyper-Box Topical Wound Oxygen System | Aoti, Ltd. | 2008 | — |
| 0 (this device) | K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K080966 | Hyper-Box Topical Wound Oxygen SystemSummary page 4…Class II Regulation Number: 21 CFR 878.5650 Product Code: KPJ Predicate Device: Hyper-Box Topical Wound Oxygen System (K080966) Device Description: The VHT-200 Wound Treatment System is a prescription medical device. This system is designed for most topic… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200) | 2025 | 0 |
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 40 years and passes through 5 companies; a new generation was cleared every 14.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K250188 (Vaporox, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPJ devicesKPJ Chamber, Oxygen, Topical, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 intended use of VHT 200 wound treatment system is to provide humidified oxygen to open, acute or chronic wounds as an adjunct therapy in wound management and treatment.
The VHT-200 wound treatment system is intended for the following kinds of wounds:
• skin ulcerations due to diabetes, venous stasis, and 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/K212121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212121: VHT-200 Wound Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212121
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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