510(k) · Cleared
ClearedO2 BOOT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gwr Medical, Llp · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Nov 7, 1997 as substantially equivalent to K831825 (Hospitak, Inc., 1983) and 3 other predicates after a 196-day review. Its family tree reaches back 1 generation to 1983. 10 later devices descend from it.
- Decided
- Nov 7, 1997
- Review
- 196 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K831825 (1983). 4 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK831825 Dispos. Hyperbaric Oxygen Cush/TraumHospitak, Inc. · 1983
- This deviceK971507 O2 BOOTGwr Medical, Llp · 1997
- Descendant · cites it directly · 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 · cites it directly · 2 of its ownK080966 Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK212121 VHT-200 Wound Treatment SystemVaporox, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK120764 Epiflo (R)Neogenix, LLC · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K023456Oxybox SystemOxyfast Corporation · 2003 · cites it directly4descendants
- K022028VX-400 Topical Hyperbaric Oxygen ChamberVascular One, Inc. · 2002 · cites it directly4descendants
- K080966Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008 · cites it directly2descendants
- K212121VHT-200 Wound Treatment SystemVaporox, Inc. · 2023 · 2 generations on1descendant
- K120764Epiflo (R)Neogenix, LLC · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831825 | Dispos. Hyperbaric Oxygen Cush/Traum | Hospitak, Inc. | 1983 | — |
| 0 (this device) | K971507 | O2 BOOT | Gwr Medical, Llp | 1997 | — |
| +1 | K023456 | Oxybox System | Oxyfast Corporation | 2003 | 2 |
| +1 | K022028 | VX-400 Topical Hyperbaric Oxygen Chamber | Vascular One, Inc. | 2002 | — |
| +1 | K080966 | Hyper-Box Topical Wound Oxygen System | Aoti, Ltd. | 2008 | — |
| +2 | K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023 | — |
| +2 | K120764 | Epiflo (R) | Neogenix, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (4)
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 |
|---|---|---|---|
| * | K831825 | Dispos. Hyperbaric Oxygen Cush/TraumSummary page 1…il 25, 1997 Name(s) of the device: 0O, Boot™ Identification of predicate device(s) The following are identified as predicate device to the O, Boot™: OXYCURE™ Cushion. K831825 OXYCURE™ Boot. K840817 Topical Hyperbaric Oxygen Chamber. K861593 Topical Sacral Hyperbaric Oxygen Chamber. K920948 Descripti… | 1983 |
| * | K840817 | Disposable, Hyperbaric Oxygen ChamberSummary page 1…the device: 0O, Boot™ Identification of predicate device(s) The following are identified as predicate device to the O, Boot™: OXYCURE™ Cushion. K831825 OXYCURE™ Boot. K840817 Topical Hyperbaric Oxygen Chamber. K861593 Topical Sacral Hyperbaric Oxygen Chamber. K920948 Description of the device The GW… | 1984 |
| * | K861593 | Topical Hyperbaric Oxygen ChamberSummary page 1…dicate device(s) The following are identified as predicate device to the O, Boot™: OXYCURE™ Cushion. K831825 OXYCURE™ Boot. K840817 Topical Hyperbaric Oxygen Chamber. K861593 Topical Sacral Hyperbaric Oxygen Chamber. K920948 Description of the device The GWR O, Boot™ is a Topical Oxygen Chamber for E… | 1986 |
| * | K920948 | Topical Sacral Hyperbaric Oxygen ChamberSummary page 1…redicate device to the O, Boot™: OXYCURE™ Cushion. K831825 OXYCURE™ Boot. K840817 Topical Hyperbaric Oxygen Chamber. K861593 Topical Sacral Hyperbaric Oxygen Chamber. K920948 Description of the device The GWR O, Boot™ is a Topical Oxygen Chamber for Extremities. It is composed of a flexible plastic fi… | 1992 |
What descends from it? (10)
3 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K023456 (Oxyfast Corporation, 2003) has gone furthest, with 4 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 | — |
What is it indicated for?
Indications for the O,;Boot are 1) skin uloerstions due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitus ulcers 3) amputations/infected stumps 4) skin grafts 5) burns 6) 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/K971507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971507: O2 BOOT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971507
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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