510(k) · Cleared
ClearedHyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyperbaric America, LLC · CBF Chamber, Hyperbaric
Cleared on Jul 25, 2008 as substantially equivalent to K934164 (Sechrist Industries, Inc., 1995) and 6 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Jul 25, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K832127 (1983). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK832127 Nautilus Monoplace Hyperbaric UnitNautilus Environmedical Systems, Inc. · 1983
- 3 generations backK974868 Sigma Plus Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1998
- 2 generations backK990927 Sigma 3400 Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1999
- 1 generation backK021693 Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002
- This deviceK081506 Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber…Hyperbaric America, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K832127 | Nautilus Monoplace Hyperbaric Unit | Nautilus Environmedical Systems, Inc. | 1983 | — |
| −3 | K974868 | Sigma Plus Monoplace Hyperbaric Chamber | Perry Baromedical Corp. | 1998 | — |
| −2 | K990927 | Sigma 3400 Monoplace Hyperbaric Chamber | Perry Baromedical Corp. | 1999 | — |
| −1 | K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 | Pan-America Hyperbarics, Inc. | 2002 | — |
| 0 (this device) | K081506 | Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems | Hyperbaric America, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 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? (7)
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…: Monoplace Hyperbaric Chamber CLASSIFICATION: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927)… | 1995 |
| * | K950386 | Model 3200P/3200PR Hyperbaric ChamberSummary page 1…CLASSIFICATION: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010)… | 1995 |
| * | K832127 | Nautilus Monoplace Hyperbaric UnitSummary page 1…ION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Pan America Hyperbarics PAH-S1 (K021693) HyperTec… | 1983 |
| * | K990927 | Sigma 3400 Monoplace Hyperbaric ChamberSummary page 1…ICATE DEVICE(S): Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Pan America Hyperbarics PAH-S1 (K021693) HyperTec 3200 (K002795) ADDRESS OF MANUF… | 1999 |
| * | K993010 | Bara-Med, Acrylic Monoplace Hyperbaric ChamberSummary page 1…rist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Pan America Hyperbarics PAH-S1 (K021693) HyperTec 3200 (K002795) ADDRESS OF MANUFACTURER: 284 Ridge Ro… | 2000 |
| * | K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Summary page 1…6) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Pan America Hyperbarics PAH-S1 (K021693) HyperTec 3200 (K002795) ADDRESS OF MANUFACTURER: 284 Ridge Road Hinckley, OH 44233 CONTACT PERSON:… | 2002 |
| * | K002795 | Model Hybrid 3200 Monoplace, Hyperbaric Therapy SystemsSummary page 1…6) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Pan America Hyperbarics PAH-S1 (K021693) HyperTec 3200 (K002795) ADDRESS OF MANUFACTURER: 284 Ridge Road Hinckley, OH 44233 CONTACT PERSON: Joe Adkins… | 2000 |
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 25 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- None of the 10 ancestors has a recall.
- 4 other devices also cite its predicate K934164.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
It is the expressed, intended use of the Hyperbaric America, LLC, Presidential Hyperbaric Chamber Systems to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in its procurement and routine use. The conditions listed as appropriate for the use of HBO by the Undersea & Hyperbaric…
Read the full statement (158 words)
It is the expressed, intended use of the Hyperbaric America, LLC, Presidential Hyperbaric Chamber Systems to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in its procurement and routine use.
The conditions listed as appropriate for the use of HBO by the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003) are as follows:
1. Air or gas embolism
2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
3. Clostridial myositis and myonecrosis
4. Crush injury, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness
6. Enhanced healing of selected problem wounds
7. Exceptional blood loss anemia
8. Necrotizing soft tissue infections
9. Osteomyelitis (refractory)
10. Delayed radiation injury (soft tissue and bony necrosis)
11. Skin grafts and flaps (compromised)
12. Thermal burns
13. Intracranial abscess
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081506 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081506: Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081506
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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