510(k) · Cleared
ClearedOxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyperbaric Technologies, Inc. · CBF Chamber, Hyperbaric
Cleared on Jun 6, 2002 as substantially equivalent to K960389 (Tampa Hyperbaric Ent., 1996) and 3 other predicates after a 357-day review. Its family tree reaches back 2 generations to 1986. 3 later devices descend from it.
- Decided
- Jun 6, 2002
- Review
- 357 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K862198 (1986). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK862198 Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services · 1986
- 1 generation backK960389 Hyperbaric ChamberTampa Hyperbaric Ent. · 1996
- This deviceK011866 Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK152223 Rectangular Multiplace Hyperbaric Chamber System Product Family with…Oxyheal Medical Systems, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK163109 OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK052866 Oxyheal 1000 Monoplace Hyperbaric ChamberOxyheal Health Group · 2005
Most influential descendants
Showing 3 of 3 · See all- K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Oxyheal Medical Systems, Inc. · 2016 · cites it directly1descendant
- K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017 · 2 generations on0descendants
- K052866Oxyheal 1000 Monoplace Hyperbaric ChamberOxyheal Health Group · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862198 | Sigma II - Dual Place Hyperbaric Chamber | Perry Baromedical Services | 1986 | — |
| −1 | K960389 | Hyperbaric Chamber | Tampa Hyperbaric Ent. | 1996 | — |
| 0 (this device) | K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series | Hyperbaric Technologies, Inc. | 2002 | — |
| +1 | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with… | Oxyheal Medical Systems, Inc. | 2016 | — |
| +2 | K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | Oxyheal Medical Systems, Inc. | 2017 | — |
| +1 | 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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K960389 | Hyperbaric ChamberSummary page 2…: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER 2029408 CLAIMED PREDICATE DEVICE(S): Tampa Hyperbaric Enterprises’ Multiplace Hyperbaric Chamber - K960389 Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K 9… | 1996 |
| * | K930748 | Sigma MP Multiplace Hyperbaric ChamberSummary page 2…29408 CLAIMED PREDICATE DEVICE(S): Tampa Hyperbaric Enterprises’ Multiplace Hyperbaric Chamber - K960389 Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K 950957 Reimers T Class Hyperbaric Facility - K95438 AD… | 1993 |
| * | K950957 | Multiplace Hyperbaric Treatment Chamber SystemSummary page 2…es’ Multiplace Hyperbaric Chamber - K960389 Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K 950957 Reimers T Class Hyperbaric Facility - K95438 ADDRESS OF MANUFACTURER: OxyHeal Health Group, Inc.… | 1995 |
| * | K954387 | T Class Hyperbaric FacilitiesSummary page 3…ace Hyperbaric Chamber (K930748), the Gulf Coast Hyperbarics, Inc. Multiplace Hyperbaric Treatment System (K950957), the Reimers Engineering T Class Hyperbaric Facility (K954387) and is proposing them as predicate devices for the OxyHeal2000. Intended Use: It is the expressed, intended use of the OxyHeal… | 1995 |
What descends from it? (3)
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K152223 (Oxyheal Medical Systems, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K960389.
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?
It is the expressed, intended use of the OxyHeal2000 hyperbaric chamber series to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class I1 prescriptive device, it is further intended for physician involvement in its procurement and routine use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K011866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011866: Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011866
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026