510(k) · Cleared
ClearedWHS-1000 Wound Healing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iyia Technologies, Inc. · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Jun 17, 2005 as substantially equivalent to K022028 (Vascular One, Inc., 2002) after a 144-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Jun 17, 2005
- Review
- 144 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831825 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK050156 WHS-1000 Wound Healing SystemIyia Technologies, Inc. · 2005
View 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) | 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 |
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 |
|---|---|---|---|
| * | K022028 | VX-400 Topical Hyperbaric Oxygen ChamberSummary page 1…for Extremities Classification No.: 878.5650 Claiming Substantial Equivalence To: VX-400 Topical Hyperbaric Oxygen Chamber, Vascular One, Inc., K022028. Device Description The Wound Treatment System is composed of a rectangular, rigid plastic shell that is o… | 2002 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- 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.
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 Misty TM Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy.
The device is intended for the treatment of 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 as stated in the FDA summary.
https://510kreport.com/device/K050156 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050156: WHS-1000 Wound Healing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050156
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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