510(k) · Cleared
ClearedSigma MP Multiplace 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 Aug 20, 1993 after a 189-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 20, 1993
- Review
- 189 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 7 citing it directly.
- This deviceK930748 Sigma MP Multiplace Hyperbaric ChamberPerry Baromedical Services · 1993
- Descendant · cites it directly · 5 of its ownK031649 SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd. · 2003
- Descendant · cites it directly · 5 of its ownK960389 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 · 2 generations on · 0 of its ownK240569 FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K031649SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd. · 2003 · cites it directly5descendants
- K960389Hyperbaric ChamberTampa Hyperbaric Ent. · 1996 · cites it directly5descendants
- 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
- K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930748 | Sigma MP Multiplace Hyperbaric Chamber | Perry Baromedical Services | 1993 | — |
| +1 | K031649 | SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities | Fink Engineering Pty, Ltd. | 2003 | — |
| +1 | 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 | — |
| +2 | K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 117 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031649 | SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities | 2003 | 5 |
| K960389 | Hyperbaric Chamber | 1996 | 5 |
| K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series | 2002 | 3 |
| K082455 | Rectangular Multiplace Hyperbaric Chamber | 2009 | 0 |
| K053498 | Hyperox 101 | 2006 | 0 |
| K030418 | Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System | 2004 | 0 |
| K021689 | Pan-America Hyperbarics, Hyperbaric Chamber System, Model Pah-M10+2 | 2002 | 0 |
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, K031649 (Fink Engineering Pty, Ltd., 2003) 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/K930748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K930748: Sigma MP Multiplace Hyperbaric Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K930748
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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