510(k) · Cleared
ClearedSechrist Monoplace Hyperbaric Oxygen 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 May 30, 2014 as substantially equivalent to K100268 (Sechrist Industries, Inc., 2010) after an 86-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 30, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950386 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950386 | Model 3200P/3200PR Hyperbaric Chamber | Sechrist Industries, Inc. | 1995 | — |
| −1 | K100268 | Sechrist Monoplace Hyperbaric Oxygen Chamber | Sechrist Industries, Inc. | 2010 | — |
| 0 (this device) | K140559 | Sechrist Monoplace Hyperbaric Oxygen Chamber | Sechrist Industries, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K100268 | Sechrist Monoplace Hyperbaric Oxygen ChamberSummary page 1…mation Legally marketed device to which we are claiming equivalence is the Sechrist Model 4100H-/1-R1 Hyperbaric Chamber originally cleared under 510(k) K100268 4. General Description A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to… | 2010 |
| † | K950386 | Model 3200P/3200PR Hyperbaric Chamber | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 1 company; a new generation was cleared every 14.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 intended use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigators in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery…
Read the full statement (250 words)
The intended use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigators in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery, trauma surgery, thoracic surgery, otolaryngology, oral and maxillofacial surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vivo or in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for third-party reimbursement and most insurance carriers have established reimbursement policy based on the recommendations.
The thirteen indications are:
1. Air or Gas embolism
2. Carbon Monoxide Poisoning
Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
3. Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemnias
5. Decompression Sickness
6. Arterial Insufficiencies
Central Retinal Artery Occlusion
Enhancement of Healing In Selected Problem Wounds
7. Severe Anemia
8. Intracranial Abscess
9. Necrotizing Soft Tissue Infections
10. Osteomyelitis (Refractory)
11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
12. Compromise Grafts and Flaps
13. Thermal Burns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140559: Sechrist Monoplace Hyperbaric Oxygen Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140559
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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