510(k) · Cleared
ClearedTopical Sacral Hyperbaric Oxygen Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topox Therapeuutic Rentals, Inc. · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Aug 11, 1992 after a 162-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Aug 11, 1992
- Review
- 162 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK920948 Topical Sacral Hyperbaric Oxygen ChamberTopox Therapeuutic Rentals, Inc. · 1992
- 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 · cites it directly · 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 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · 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 · cites it directly4descendants
- 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) | K920948 | Topical Sacral Hyperbaric Oxygen Chamber | Topox Therapeuutic Rentals, Inc. | 1992 | — |
| +1 | K971507 | O2 BOOT | Gwr Medical, Llp | 1997 | — |
| +2 | K023456 | Oxybox System | Oxyfast Corporation | 2003 | 2 |
| +1 | 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 | 2 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 123 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?
- 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/K920948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920948: Topical Sacral 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/K920948
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026