510(k) · Cleared
ClearedOxyheal 1000 Monoplace Hyperbaric Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxyheal Health Group · CBF Chamber, Hyperbaric
Cleared on Dec 13, 2005 as substantially equivalent to K020974 (Environmental Tectonics Corp., 2002) and 1 other predicate after a 63-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Dec 13, 2005
- Review
- 63 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K862198 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK862198 Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services · 1986
- 2 generations backK960389 Hyperbaric ChamberTampa Hyperbaric Ent. · 1996
- 1 generation backK011866 Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002
- This deviceK052866 Oxyheal 1000 Monoplace Hyperbaric ChamberOxyheal Health Group · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862198 | Sigma II - Dual Place Hyperbaric Chamber | Perry Baromedical Services | 1986 | — |
| −2 | K960389 | Hyperbaric Chamber | Tampa Hyperbaric Ent. | 1996 | — |
| −1 | K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series | Hyperbaric Technologies, Inc. | 2002 | — |
| 0 (this device) | K052866 | Oxyheal 1000 Monoplace Hyperbaric Chamber | Oxyheal Health Group | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K020974 | Bara-Med Acrylic Monoplace Hyperbaric ChamberSummary page 1…amber Classification: 73 CBF, 21 CFR 868.5470 Establishment Registration Number: 2029408 Claimed Predicate Device(s) Environmental Tectonics Corp. 'Bara-Med" (K020974) Hyperbaric Technologies, Inc. 'OxyHeal 2000' (K01 1866) ADDRESS OF MANUFACTURER: OxyHeal Health… | 2002 |
| * | K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesSummary page 1…Registration Number: 2029408 Claimed Predicate Device(s) Environmental Tectonics Corp. 'Bara-Med" (K020974) Hyperbaric Technologies, Inc. 'OxyHeal 2000' (K01 1866) ADDRESS OF MANUFACTURER: OxyHeal Health Group P.O. Box 1987… | 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 19 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K020974.
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?
1. Air or Gas Embolism
2. Carbon Monoxide Poisoning
Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
3. Clostridal Myositis and Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome, and other Acute Traumatic Ischemias
5. Decompression Sickness
6. Enhancement of Healing in Selected Problem Wounds
7. Exceptional Blood Loss (Anemia)
8. Intracranial Abscess
9. Necrotizing Soft Tissue Infections
10. Osteomyelitis (Refractory)
11. Delayed Radiation Injury (Sofi Tissue and Bony Necrosis)
12. Skin Grafts & Flaps (Compromised)
13. Therm:! Burns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052866: Oxyheal 1000 Monoplace Hyperbaric Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052866
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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