510(k) · Cleared
ClearedHyperbaric Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tampa Hyperbaric Ent. · CBF Chamber, Hyperbaric
Cleared on Dec 5, 1996 as substantially equivalent to K862198 (Perry Baromedical Services, 1986) and 1 other predicate after a 318-day review. Its family tree reaches back 1 generation to 1986. 5 later devices descend from it.
- Decided
- Dec 5, 1996
- Review
- 318 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K862198 (1986). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK862198 Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services · 1986
- This deviceK960389 Hyperbaric ChamberTampa Hyperbaric Ent. · 1996
- Descendant · cites it directly · 3 of its ownK011866 Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK152223 Rectangular Multiplace Hyperbaric Chamber System Product Family with…Oxyheal Medical Systems, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK163109 OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK052866 Oxyheal 1000 Monoplace Hyperbaric ChamberOxyheal Health Group · 2005
- Descendant · cites it directly · 0 of its ownK030418 Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemMakai Marine Industries, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K011866Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002 · cites it directly3descendants
- K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Oxyheal Medical Systems, Inc. · 2016 · 2 generations on1descendant
- K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017 · 3 generations on0descendants
- K052866Oxyheal 1000 Monoplace Hyperbaric ChamberOxyheal Health Group · 2005 · 2 generations on0descendants
- K030418Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemMakai Marine Industries, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862198 | Sigma II - Dual Place Hyperbaric Chamber | Perry Baromedical Services | 1986 | — |
| 0 (this device) | K960389 | Hyperbaric Chamber | Tampa Hyperbaric Ent. | 1996 | — |
| +1 | K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series | Hyperbaric Technologies, Inc. | 2002 | — |
| +2 | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with… | Oxyheal Medical Systems, Inc. | 2016 | — |
| +3 | K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | Oxyheal Medical Systems, Inc. | 2017 | — |
| +2 | K052866 | Oxyheal 1000 Monoplace Hyperbaric Chamber | Oxyheal Health Group | 2005 | — |
| +1 | K030418 | Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System | Makai Marine Industries, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K862198 | Sigma II - Dual Place Hyperbaric ChamberSummary page 3…3 === From: Michael Capria To: Joanna Weitershausen Jale: T2/4/9€ Tim L RS 1st Comparison Table Information: Predicate Device Proteus Dual-Place Hyperbaric Chamber # K862198 Perry Baromedical, Inc. FDA # 1036464 Labeling Has required labels along with control panel labels Intended Use Ilas all the prio… | 1986 |
| * | K930748 | Sigma MP Multiplace Hyperbaric Chamber | 1993 |
What descends from it? (5)
2 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?
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?
Decompression sickness; Carbon monoxide with or without cyanide poisoning; Smoke inhalation; Exceptional blood loss; Clostridial myonecrosis; Crush injury, compartment syndrome and acute traumatic ischemias; Selected Problem Wounds; Compromised skin grafts; Osteomyelitis; Osteoradionecrosis; Thermal burns; Necrotizing soft tissue infections.
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/K960389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960389: Hyperbaric Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960389
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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