Devo Oxygen Concentrator Model 955

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K792385 ↗

FDA Product Code

CAW

Device Class

Class II

Regulation

21 CFR Part 868.5440

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• De Vo/44 Oxygen Concentrator #444

  Class II

  FDA 510(k) K830174 Active Cleared 17 Feb 1983

• Devo/MC44 Oxygen Concentrator

  Class II

  FDA 510(k) K872470 Active Cleared 3 Aug 1987

• Devilbiss Model 8500D

  Class II

  FDA 510(k) K874041 Active Cleared 23 Dec 1987

• Pulmo-Aide Model 5610D

  Class I

  FDA 510(k) K854520 Active Cleared 9 Dec 1985

• Devo/MC29 Oxygen Concentrator MC29D

  Class II

  FDA 510(k) K852209 Active Cleared 24 Jun 1985

• Surveyor I, Respiratory Computer System

  Class II

  FDA 510(k) K801526 Active Cleared 21 Jul 1980

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• What is the primary use case for the Devo Oxygen Concentrator Model 955 in clinical settings?

  The Devo Oxygen Concentrator Model 955 is designed to concentrate ambient air and deliver continuous oxygen therapy in medical environments where a reliable oxygen supply is essential. This includes patient care settings, particularly where anesthesia applications are performed, ensuring a steady flow of oxygen without the need for external oxygen cylinders.

• Is the Devo Oxygen Concentrator Model 955 intended for single-use or reusable applications?

  The Devo Oxygen Concentrator Model 955 is explicitly supplied as a reusable medical instrument. It is not intended for single-use and is meant to be maintained and used repeatedly in clinical settings, adhering to standard reusable medical device protocols.

• What regulatory pathway does the Devo Oxygen Concentrator Model 955 follow in the U.S., and what does this mean for its use?

  The device follows the FDA 510(k) clearance pathway (K792385) and is classified as a Class II medical device. This means it has been determined to be substantially equivalent to a legally marketed predicate device and is authorized for distribution in the U.S. under FDA regulations, ensuring it meets established safety and performance standards for portable oxygen generators.

• Does the Devo Oxygen Concentrator Model 955 require sterile conditions for operation?

  No, the Devo Oxygen Concentrator Model 955 is not sterile and is designed for use in non-sterile clinical environments. It is intended for general medical settings where sterility is not a requirement for its operation, such as anesthesia rooms or patient care areas.

• What specialties or clinical applications is this device primarily associated with, based on its regulatory documentation?

  The device is primarily associated with anesthesiology, as indicated by its regulatory submissions to the FDA’s Anesthesiology Advisory Committee (AN). While it can be used in broader patient care environments requiring oxygen therapy, its classification and advisory committee designation highlight its relevance to anesthesia applications.