510(k) · Cleared
ClearedSigma II - Dual Place Hyperbaric Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perry Baromedical Services · CBF Chamber, Hyperbaric
Cleared on Nov 12, 1986 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Nov 12, 1986
- Review
- 156 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK862198 Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services · 1986
- Descendant · cites it directly · 5 of its ownK960389 Hyperbaric ChamberTampa Hyperbaric Ent. · 1996
- Descendant · 2 generations on · 3 of its ownK011866 Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK981938 Tampa Hyperbaric Monoplace ChamberTampa Hyperbaric Ent. · 1999
- Descendant · 2 generations on · 2 of its ownK021693 Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK152223 Rectangular Multiplace Hyperbaric Chamber System Product Family with…Oxyheal Medical Systems, Inc. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K960389Hyperbaric ChamberTampa Hyperbaric Ent. · 1996 · cites it directly5descendants
- K011866Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002 · 2 generations on3descendants
- K981938Tampa Hyperbaric Monoplace ChamberTampa Hyperbaric Ent. · 1999 · cites it directly3descendants
- K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002 · 2 generations on2descendants
- K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Oxyheal Medical Systems, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862198 | Sigma II - Dual Place Hyperbaric Chamber | Perry Baromedical Services | 1986 | — |
| +1 | K960389 | Hyperbaric Chamber | Tampa Hyperbaric Ent. | 1996 | — |
| +2 | K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series | Hyperbaric Technologies, Inc. | 2002 | — |
| +1 | K981938 | Tampa Hyperbaric Monoplace Chamber | Tampa Hyperbaric Ent. | 1999 | — |
| +2 | K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 | Pan-America Hyperbarics, Inc. | 2002 | — |
| +3 | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with… | Oxyheal Medical Systems, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 124 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?
- Of its descendants, K960389 (Tampa Hyperbaric Ent., 1996) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K862198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K862198: Sigma II - Dual Place 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/K862198
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026