510(k) · Cleared
ClearedModel 3200P/3200PR Hyperbaric Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sechrist Industries, Inc. · CBF Chamber, Hyperbaric
Cleared on Jun 13, 1995 after a 132-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jun 13, 1995
- Review
- 132 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 6 citing it directly.
- This deviceK950386 Model 3200P/3200PR Hyperbaric ChamberSechrist Industries, Inc. · 1995
- Descendant · cites it directly · 3 of its ownK993010 Bara-Med, Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2000
- Descendant · cites it directly · 2 of its ownK021693 Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK100268 Sechrist Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK052713 Model 3300E/ER Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK140559 Sechrist Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K993010Bara-Med, Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2000 · cites it directly3descendants
- K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002 · cites it directly2descendants
- K100268Sechrist Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2010 · cites it directly1descendant
- K052713Model 3300E/ER Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2005 · cites it directly1descendant
- K140559Sechrist Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950386 | Model 3200P/3200PR Hyperbaric Chamber | Sechrist Industries, Inc. | 1995 | — |
| +1 | K993010 | Bara-Med, Acrylic Monoplace Hyperbaric Chamber | Environmental Tectonics Corp. | 2000 | — |
| +1 | K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 | Pan-America Hyperbarics, Inc. | 2002 | — |
| +1 | K100268 | Sechrist Monoplace Hyperbaric Oxygen Chamber | Sechrist Industries, Inc. | 2010 | — |
| +1 | K052713 | Model 3300E/ER Monoplace Hyperbaric Oxygen Chamber | Sechrist Industries, Inc. | 2005 | 2 |
| +2 | K140559 | Sechrist Monoplace Hyperbaric Oxygen Chamber | Sechrist Industries, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993010 | Bara-Med, Acrylic Monoplace Hyperbaric Chamber | 2000 | 3 |
| K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 | 2002 | 2 |
| K100268 | Sechrist Monoplace Hyperbaric Oxygen Chamber | 2010 | 1 |
| K052713 | Model 3300E/ER Monoplace Hyperbaric Oxygen Chamber | 2005 | 1 |
| K081506 | Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems | 2008 | 0 |
| K972908 | Sands Series Iii Hyperbaric Chamber | 1998 | 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, K993010 (Environmental Tectonics Corp., 2000) has gone furthest, with 3 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/K950386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950386: Model 3200P/3200PR 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/K950386
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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