510(k) · Decided
DecidedBara-Med Acrylic Monoplace Hyperbaric Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Environmental Tectonics Corp. · CBF Chamber, Hyperbaric
Cleared on Jun 26, 2002 as substantially equivalent to K934164 (Sechrist Industries, Inc., 1995) after a 92-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Jun 26, 2002
- Review
- 92 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934164 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK934164 Model 2500E/2500ER Hyperbaric ChamberSechrist Industries, Inc. · 1995
- This deviceK020974 Bara-Med Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2002
- Descendant · cites it directly · 0 of its ownK072427 Sigma Series Hyperbaric ChamberPerry Baromedical Corp. · 2008
- Descendant · cites it directly · 0 of its ownK052866 Oxyheal 1000 Monoplace Hyperbaric ChamberOxyheal Health Group · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934164 | Model 2500E/2500ER Hyperbaric Chamber | Sechrist Industries, Inc. | 1995 | — |
| 0 (this device) | K020974 | Bara-Med Acrylic Monoplace Hyperbaric Chamber | Environmental Tectonics Corp. | 2002 | — |
| +1 | K072427 | Sigma Series Hyperbaric Chamber | Perry Baromedical Corp. | 2008 | — |
| +1 | K052866 | Oxyheal 1000 Monoplace Hyperbaric Chamber | Oxyheal Health Group | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934164 | Model 2500E/2500ER Hyperbaric ChamberSummary page 1…crry Baromedical’s Sigma 1 (pre-amendment devicc:) o Sechrist Industry’s Sechrist 2500 (pre-amendment device) 4 Scchrist Tndustry’s Sechrist 2500E (K934164) 4 Scchrist Industry’s Sechrist 3200 (K950356) DEVICE DESCRIPTION / SUBSTANTIALdEQUIVALENCF:… | 1995 |
| Kept off the family tree | K950356 | Sechrist Industry’s Sechrist 3200 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…o Sechrist Industry’s Sechrist 2500 (pre-amendment device) 4 Scchrist Tndustry’s Sechrist 2500E (K934164) 4 Scchrist Industry’s Sechrist 3200 (K950356) DEVICE DESCRIPTION / SUBSTANTIALdEQUIVALENCF:… | |
| * | — | Dixie Manufacturing Co.’s Dixie 800-45 Named without a submission number | |
| * | — | Perry Baromedical’s Sigma 1 Named without a submission number | |
| * | — | Sechrist Industry’s Sechrist 2500 Named without a submission number |
What descends from it? (2)
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?
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 BARA-MED Monoplace Hyperbaric Chamber is a prescription device intended
for the whole body administration of oxygen to a patient at pressures not exceeding
3 ATA (Atmospheres Absolute).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020974: Bara-Med Acrylic Monoplace Hyperbaric Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020974
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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