510(k) · Cleared
ClearedTampa Hyperbaric Monoplace 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 Jul 6, 1999 as substantially equivalent to K862198 (Perry Baromedical Services, 1986) after a 399-day review. Its family tree reaches back 1 generation to 1986. 3 later devices descend from it.
- Decided
- Jul 6, 1999
- Review
- 399 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862198 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK862198 Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services · 1986
- This deviceK981938 Tampa Hyperbaric Monoplace ChamberTampa Hyperbaric Ent. · 1999
- Descendant · cites it directly · 2 of its ownK021693 Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK081506 Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber…Hyperbaric America, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK053498 Hyperox 101Wjo, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002 · cites it directly2descendants
- K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC · 2008 · 2 generations on0descendants
- K053498Hyperox 101Wjo, Inc. · 2006 · 2 generations on0descendants
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) | K981938 | Tampa Hyperbaric Monoplace Chamber | Tampa Hyperbaric Ent. | 1999 | — |
| +1 | K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 | Pan-America Hyperbarics, Inc. | 2002 | — |
| +2 | K081506 | Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems | Hyperbaric America, LLC | 2008 | — |
| +2 | K053498 | Hyperox 101 | Wjo, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (1)
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 4…clitis (unmanageable bone disease). Summary comparison of our device to the legally marketed predicate device: Predicate Device Proteus Dual-Place Hyperbaric Chamber # K862198 Pressurization Rate Variable contral (from maximum 10 psi (@ minute) slower for less adaptable patients (<1 psi @ minute) Maximum… | 1986 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 | 2002 | 2 |
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?
Carbon monoxide poisoning with or without cyanide complications
Smoke inhalation
Decompression sickness
Exceptional blood loss or anemia
Clostridial myonecrosis (gangrene)
Selected problem chronic wounds
Crush injury, compartment syndrome and acute traumatic ischemias
Compromised skin grafts
Osteomyelitis
Thermal burns
Osteoradionecrosis (radiation burns)
Necrotizing soft tissue infections
Air or Gas Embolism
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/K981938 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981938: Tampa Hyperbaric Monoplace Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981938
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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