510(k) · Cleared
ClearedO.S.C.a.R. (Operating System for Control and Record Keeping)
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 Aug 13, 2010 after a 319-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 13, 2010
- Review
- 319 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 O.S.CAR. system is intended for use as an ancillary device for the support of whole-body oxygen administration to a patient at greater than ambient atmospheric pressure (hyperbaric oxygen) as prescribed by a physician. It is a device intended to provide control of Pressure Vessels for Human Occupancy without change to their established indications for use. The specific manufacturer's devices intended for use are Environmental Tectonics Corp.'s…
Read the full statement (205 words)
The O.S.CAR. system is intended for use as an ancillary device for the support of whole-body oxygen administration to a patient at greater than ambient atmospheric pressure (hyperbaric oxygen) as prescribed by a physician. It is a device intended to provide control of Pressure Vessels for Human Occupancy without change to their established indications for use. The specific manufacturer's devices intended for use are Environmental Tectonics Corp.'s BARAMED 30' and XD monoplace models.
The FDA has cleared the use of hyperbaric chambers under 13 specific medical conditions that are based on the Undersea and Hyperbaric Medicine Society (UHMS)'s indications. These are:
a 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 lschemias
* 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
It is a prescription device that is intended for sale and use by or on the order and under the medical supervision of a physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092991: O.S.C.a.R. (Operating System for Control and Record Keeping).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092991
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026