Devilbiss Oxygen Cylinder Filling System 535 Series

• • Terminated Z-0038-2007 FDA Unclassified (pre-2012) ·initiated 24 Aug 2006

  Potential for oxygen cylinders to not fill completely

510(k) Number

K053240 ↗

FDA Product Code

CAW

Device Class

Class II

Regulation

21 CFR Part 868.5440

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What is the Devilbiss Oxygen Cylinder Filling System 535 Series used for?

  The Devilbiss Oxygen Cylinder Filling System 535 Series is designed to concentrate oxygen from ambient air to a purity of 93% (± 3%) and pressurize it into portable oxygen cylinders. It is specifically intended for refilling cylinders used in ambulatory patient care, ensuring patients have access to oxygen outside clinical environments.

• How is the Devilbiss 535 Series supplied and maintained?

  The system is supplied as a stationary device for repeated use in medical environments. It does not require sterilization between uses but must be maintained according to the manufacturer’s guidelines to ensure proper functionality and safety. Regular maintenance helps preserve performance and extends the device’s operational lifespan.

• Is the Devilbiss 535 Series single-use or reusable?

  The Devilbiss Oxygen Cylinder Filling System 535 Series is designed for repeated use in clinical settings. It is not a single-use device, meaning it can be utilized multiple times as long as it is properly maintained and serviced according to manufacturer recommendations.

• What oxygen purity does the 535 Series produce, and how does it affect cylinder refilling?

  The system concentrates oxygen to a purity of 93% (± 3%). This level of purity is sufficient for refilling portable oxygen cylinders used in ambulatory patient care, ensuring patients receive a reliable oxygen supply while maintaining safety standards for clinical use.

• What regulatory approval does the Devilbiss 535 Series hold?

  The Devilbiss Oxygen Cylinder Filling System 535 Series holds FDA 510K clearance and is classified as a Class II medical device. This approval indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness.