510(k) · Cleared
ClearedSigma Plus Monoplace Hyperbaric Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perry Baromedical Corp. · CBF Chamber, Hyperbaric
Cleared on Jul 2, 1998 as substantially equivalent to K832127 (Nautilus Environmedical Systems, Inc., 1983) after a 185-day review. Its family tree reaches back 1 generation to 1983. 5 later devices descend from it.
- Decided
- Jul 2, 1998
- Review
- 185 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832127 (1983). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK832127 Nautilus Monoplace Hyperbaric UnitNautilus Environmedical Systems, Inc. · 1983
- This deviceK974868 Sigma Plus Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1998
- Descendant · cites it directly · 4 of its ownK990927 Sigma 3400 Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1999
- Descendant · 2 generations on · 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 ownK072427 Sigma Series Hyperbaric ChamberPerry Baromedical Corp. · 2008
- Descendant · 3 generations on · 0 of its ownK053498 Hyperox 101Wjo, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K990927Sigma 3400 Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1999 · cites it directly4descendants
- K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002 · 2 generations on2descendants
- K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC · 2008 · 2 generations on0descendants
- K072427Sigma Series Hyperbaric ChamberPerry Baromedical Corp. · 2008 · 2 generations on0descendants
- K053498Hyperox 101Wjo, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832127 | Nautilus Monoplace Hyperbaric Unit | Nautilus Environmedical Systems, Inc. | 1983 | — |
| 0 (this device) | K974868 | Sigma Plus Monoplace Hyperbaric Chamber | Perry Baromedical Corp. | 1998 | — |
| +1 | K990927 | Sigma 3400 Monoplace Hyperbaric Chamber | Perry Baromedical Corp. | 1999 | — |
| +2 | 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 | K072427 | Sigma Series Hyperbaric Chamber | Perry Baromedical Corp. | 2008 | — |
| +3 | K053498 | Hyperox 101 | Wjo, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K832127 | Nautilus Monoplace Hyperbaric UnitSummary page 1…edical Corporation SIGMA Plus Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA 1 Monoplace Hyperbaric Chamber, [510(k) K832127]. The SIGMA Plus has the same intended use and the same technological characteristics as the SIGMA I predicate device. The scope… | 1983 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990927 | Sigma 3400 Monoplace Hyperbaric Chamber | 1999 | 4 |
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?
The monoplace hyperbaric chamber is indicated for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows:
Air or Gas Embolism
Carbon Monoxide / Smoke Inhalation
Compromised Skin Grafts and Flaps
Crush Injuries / Acute Traumatic Ischemias
Decompression Sickness
Enhanced Healing in Selected Problem Wounds
Exceptional Blood Loss (Anemia)
Gas Gangrene (Clostridial Myonecrosis)
Intracranial Abscess
Necrotizing Soft Tissue Infections
Radiation Tissue Damage (Osteoradionecrosis)
Refractory Osteomyelitis
Thermal Burns
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/K974868 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974868: Sigma Plus Monoplace 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/K974868
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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