510(k) · Cleared
ClearedHyperox 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wjo, Inc. · CBF Chamber, Hyperbaric
Cleared on Mar 15, 2006 as substantially equivalent to K031649 (Fink Engineering Pty, Ltd., 2003) and 2 other predicates after an 89-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Mar 15, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K832127 (1983). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK832127 Nautilus Monoplace Hyperbaric UnitNautilus Environmedical Systems, Inc. · 1983
- 3 generations backK974868 Sigma Plus Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1998
- 2 generations backK990927 Sigma 3400 Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1999
- 1 generation backK021693 Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002
- This deviceK053498 Hyperox 101Wjo, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K832127 | Nautilus Monoplace Hyperbaric Unit | Nautilus Environmedical Systems, Inc. | 1983 | — |
| −3 | K974868 | Sigma Plus Monoplace Hyperbaric Chamber | Perry Baromedical Corp. | 1998 | — |
| −2 | K990927 | Sigma 3400 Monoplace Hyperbaric Chamber | Perry Baromedical Corp. | 1999 | — |
| −1 | K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 | Pan-America Hyperbarics, Inc. | 2002 | — |
| 0 (this device) | K053498 | Hyperox 101 | Wjo, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 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 CBF? 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 CBF device
- #1 K240569 FESL FINK Chamber; FEDL FINK Chamber; FETL…score 8.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K031649 | SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesSummary page 3…pressurization and the intended use of the HyperOx Hyperbaric Oxygen Treatment Chamber is substantially equivalent to the Fink Engineering Pty. Ltd models SL8/DLS/TL20 (K031649), Pan-American Hyperbarics, Inc PAH-S 1 Chamber (K021693), and Perry Sigmna MP Hyperbaric Chamber (K930748) and is proposing them… | 2003 |
| * | K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Summary page 1…Predicate Device(s): Fink Engineering Pty. Ltd Models S5L8/DL8/TL,2O (1(031649) Pan-American Hlyerbarics, Inc. PAH-SlI - K02 1693 Perry Sigma MP Hyperbaric Chamber -K930748 5-1 === Page 2 ==… | 2002 |
| * | K930748 | Sigma MP Multiplace Hyperbaric ChamberSummary page 1…. Ltd Models S5L8/DL8/TL,2O (1(031649) Pan-American Hlyerbarics, Inc. PAH-SlI - K02 1693 Perry Sigma MP Hyperbaric Chamber -K930748 5-1 SUMMARY The Undersea and Hyperbaric Medical Society (UMHS) defi… | 1993 |
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 23 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 14 ancestors has a recall.
- 3 other devices also cite its predicate K031649.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBF
87in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBF
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBF
25in 2025
MAUDE reports naming product code CBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 3 | 134 | 2 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 87 | 0 | 11 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 1 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Air or gas embolism
Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
Clostridial myositis and myonecrosis
Crush injury, compartment syndrome, and other acute traumatic ischememias
iDecompression sickness
Enhanced of selected problem wounds
Exceptional blood loss anemia
Necrotizing soft tissue infections
Osteomyelitis (refractory)
Delayed radiation injury (soft tissue and bony necrosis)
Skin grafts and flaps (compromised)
Thermal bums
Intercranial abscess
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053498: Hyperox 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053498
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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