510(k) · Cleared
ClearedBara-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 May 30, 2000 as substantially equivalent to K934164 (Sechrist Industries, Inc., 1995) and 1 other predicate after a 266-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- May 30, 2000
- Review
- 266 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934164 (1995). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK934164 Model 2500E/2500ER Hyperbaric ChamberSechrist Industries, Inc. · 1995
- This deviceK993010 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 · 0 of its ownK081506 Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber…Hyperbaric America, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK053498 Hyperox 101Wjo, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002 · cites it directly2descendants
- K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC · 2008 · cites it directly0descendants
- K053498Hyperox 101Wjo, Inc. · 2006 · 2 generations on0descendants
View 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) | 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 | K081506 | Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems | Hyperbaric America, LLC | 2008 | — |
| +2 | K053498 | Hyperox 101 | Wjo, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934164 | Model 2500E/2500ER Hyperbaric ChamberSummary page 1…5 (pre-amendment device) Perry Baromedical’s Sigma I (pre-amendment device) Sechrist Industry’s Sechrist 2500 (pre-amendment device) Sechrist Industry’s Sechrist 2500E (K934164) Sechrist Industry’s Sechrist 3200 (K950386) LR IR R JER 2 \\\DC - 68874/1 - 0939120.01 DEVICE DESCRIPTION/SUB… | 1995 |
| * | K950386 | Model 3200P/3200PR Hyperbaric ChamberSummary page 1…Sigma I (pre-amendment device) Sechrist Industry’s Sechrist 2500 (pre-amendment device) Sechrist Industry’s Sechrist 2500E (K934164) Sechrist Industry’s Sechrist 3200 (K950386) LR IR R JER 2 \\\DC - 68874/1 - 0939120.01 DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE The BARA-MED® and its p… | 1995 |
| * | — | Dixie Manufacturing Co.’s Dixie 800-45 Named without a submission number | |
| * | — | Perry Baromedical’s Sigma I Named without a submission number | |
| * | — | Sechrist Industry’s Sechrist 2500 Named without a submission number |
What descends from it? (3)
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?
All of the contemporary substantially equivalent systems listed in Attachment 12 are used for the same indications as listed in the Hyperbaric Oxygen Therapy: Committee Report, Undersea and Hyperbaric Medical Society, Inc., Revised 1999. Air or Gas Embolism Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning Clostridial Myositis and Myonecrosis (Gas Gangrene) Crush Injury, Compartment Syndrome and other Acute…
Read the full statement (100 words)
All of the contemporary substantially equivalent systems listed in Attachment 12 are used for the same indications as listed in the Hyperbaric Oxygen Therapy: Committee Report, Undersea and Hyperbaric Medical Society, Inc., Revised 1999.
Air or Gas Embolism
Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning
Clostridial Myositis and Myonecrosis (Gas Gangrene)
Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias
Decompression Sickness
Enhancement of Healing in Selected Problem Wounds
Exceptional Blood Loss (Anemia)
Intracranial Abscess
Necrotizing Soft Tissue Infections
Osteomyelitis (Refractory)
Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
Skin Grafts and Flaps (Compromised)
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/K993010 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993010: Bara-Med, Acrylic 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/K993010
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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