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O.S.C.A.R. (Operating System for Control and Record Keeping)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092991

by Environmental Tectonics Corp.

Identifiers

510(k) Number
K092991 FDA 510(k)
FDA Product Code
CBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5470 FDA 510(k)
Regulation Number
868.5470 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

O.S.C.A.R. (Operating System for Control and Record Keeping) is a chamber, hyperbaric device used as an ancillary control system for hyperbaric oxygen therapy. It functions to operate, control, and record whole-body hyperbaric oxygen therapy treatments in human occupancy pressure vessels.

The device is operated by trained clinical staff in a hospital or clinical setting under physician supervision. It is supplied as a stand-alone unit and is authorized under FDA 510(k) clearance K092991, with product code CBF and regulation number 868.5470, classified as a Class II device for anesthesiology applications.

Frequently asked questions

What is the O.S.C.A.R. device used for?

The O.S.C.A.R. is a chamber, hyperbaric device that functions as an ancillary control system for hyperbaric oxygen therapy. It operates, controls, and records whole-body hyperbaric oxygen therapy treatments in human occupancy pressure vessels, and is used by trained clinical staff under physician supervision in hospital or clinical settings.

How is the O.S.C.A.R. device supplied and configured for use?

The O.S.C.A.R. is supplied as a stand-alone unit designed to integrate with hyperbaric oxygen therapy systems. It is not a pressure vessel itself but serves as an external control and record-keeping system for whole-body hyperbaric treatments, operated by trained personnel in clinical environments.

What regulatory pathway was used for the O.S.C.A.R. device, and what is its classification?

The O.S.C.A.R. received FDA 510(k) clearance under K092991 and is classified as a Class II medical device. It is regulated under product code CBF and regulation number 868.5470, with a medical specialty designation in anesthesiology, based on a traditional submission found substantially equivalent to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: O.s.c.a.r. (Operating System for Control and Record Keeping), O.s.c.a.r. (Operating System for Control and Record Keeping), ETC Biomedical Systems Offers New FDA Cleared Hyperbaric Oxygen Therapy ..., Environmental Tectonics Corp FDA Filings

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Environmental Tectonics Corp.

Sources (1)

  • FDA 510(k) K092991 24 fields · synced Sep 19, 2026