510(k) · Cleared
Recalled · Class II · 2008Model 3300E/ER 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 Oct 28, 2005 as substantially equivalent to K950386 (Sechrist Industries, Inc., 1995) after a 29-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Oct 28, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- CBF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950386 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK950386 Model 3200P/3200PR Hyperbaric ChamberSechrist Industries, Inc. · 1995
- This deviceK052713 Model 3300E/ER Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK072427 Sigma Series Hyperbaric ChamberPerry Baromedical Corp. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072427Sigma Series Hyperbaric ChamberPerry Baromedical Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950386 | Model 3200P/3200PR Hyperbaric Chamber | Sechrist Industries, Inc. | 1995 | — |
| 0 (this device) | K052713 | Model 3300E/ER Monoplace Hyperbaric Oxygen Chamber | Sechrist Industries, Inc. | 2005 | — |
| +1 | K072427 | Sigma Series Hyperbaric Chamber | Perry Baromedical Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K950386 | Model 3200P/3200PR Hyperbaric ChamberSummary page 2…n change controls. Substantially Equivalent Devices Manufacturer Product Sechrist Industries, Inc. Model 3200P/PR K950386 Anaheim, CA Intended Use The intended use of the Sechrist Model 3300E/ER Hyperbaric Chamber is… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072427 | Sigma Series Hyperbaric Chamber | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2008 | Class II | Z-0208-2013 | Software design | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber. |
| Aug 28, 2008 | Class II | Z-0209-2013 | Software design | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber. |
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 intended use of the Sechrist Model 3300E/ER Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. Specific indications for use of 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).…
Read the full statement (276 words)
The intended use of the Sechrist Model 3300E/ER Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure.
Specific indications for use of 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 these recommendations. The thirteen indications are:
1. Air or Gas Embolism
2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning
3. Clostridial Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
5. Decompression Sickness
6. Enhancement of Healing in Selected Problem Wounds
7. Exceptional Blood Loss (Anemia)
8. Intracranial Abscess
9. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
10. Osteomyelitis (Refractory)
11. Radiation Tissue Damage (Osteoradionecrosis)
12. Skin Grafts and Flaps (Compromised)
13. Thermal Burns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052713: Model 3300E/ER 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/K052713
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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