510(k) · Cleared
ClearedTopical Hyperbaric Oxygen Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stephenson Industries, Inc. · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on May 12, 1986 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- May 12, 1986
- Review
- 13 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK861593 Topical Hyperbaric Oxygen ChamberStephenson Industries, Inc. · 1986
- Descendant · cites it directly · 10 of its ownK971507 O2 BOOTGwr Medical, Llp · 1997
- Descendant · 2 generations on · 4 of its ownK023456 Oxybox SystemOxyfast Corporation · 2003 · Recalled
- Descendant · 2 generations on · 4 of its ownK022028 VX-400 Topical Hyperbaric Oxygen ChamberVascular One, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK080966 Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008
- Descendant · 3 generations on · 1 of its ownK212121 VHT-200 Wound Treatment SystemVaporox, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K971507O2 BOOTGwr Medical, Llp · 1997 · cites it directly10descendants
- K023456Oxybox SystemOxyfast Corporation · 2003 · 2 generations on4descendants
- K022028VX-400 Topical Hyperbaric Oxygen ChamberVascular One, Inc. · 2002 · 2 generations on4descendants
- K080966Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008 · 2 generations on2descendants
- K212121VHT-200 Wound Treatment SystemVaporox, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861593 | Topical Hyperbaric Oxygen Chamber | Stephenson Industries, Inc. | 1986 | — |
| +1 | K971507 | O2 BOOT | Gwr Medical, Llp | 1997 | — |
| +2 | K023456 | Oxybox System | Oxyfast Corporation | 2003 | 2 |
| +2 | K022028 | VX-400 Topical Hyperbaric Oxygen Chamber | Vascular One, Inc. | 2002 | — |
| +2 | K080966 | Hyper-Box Topical Wound Oxygen System | Aoti, Ltd. | 2008 | — |
| +3 | K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971507 | O2 BOOT | 1997 | 10 |
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?
- Of its descendants, K971507 (Gwr Medical, Llp, 1997) has gone furthest, with 10 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.
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 | — |
https://510kreport.com/device/K861593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K861593: 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/K861593
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026