# K092991: O.S.C.a.R. (Operating System for Control and Record Keeping)

- Pathway: 510(k) (Traditional)
- Applicant: Environmental Tectonics Corp.
- Decided: Aug 13, 2010 after 319 days
- Product code: CBF (Chamber, Hyperbaric)
- Device class: 2
- Regulation: 21 CFR 868.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K092991
Methodology: https://510kreport.com/methodology