Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 Series

• • Ongoing Z-1727-2025 FDA Class I ·initiated 11 Apr 2025

  Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

• • Ongoing Z-1558-2023 FDA Class II ·initiated 9 Mar 2023

  The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

• • Ongoing Z-0724-2023 FDA Class II ·initiated 18 Nov 2022

  The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

510(k) Number

K071397 ↗

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 5L Compact Oxygen Concentrator (Model 525 Series) used for?

  This device concentrates ambient air to deliver oxygen therapy for continuous or intermittent use. It is designed for clinical settings like anesthesia and respiratory care, as well as home therapy environments where portable oxygen delivery is required. The compact design ensures ease of use in spaces with limited room, while its flow rates of up to 5 liters per minute and oxygen purity of 87–96% meet a range of patient needs.

• How is the Devilbiss 5L Compact Oxygen Concentrator (Model 525 Series) supplied?

  The Model 525 Series is supplied as a reusable medical device. It is not single-use and requires maintenance, cleaning, and periodic servicing to ensure proper functionality and safety. The device operates on standard electrical power and includes built-in safety alarms for operational monitoring, making it suitable for long-term use in clinical or home settings.

• Is the Devilbiss 5L Compact Oxygen Concentrator sterile?

  No, the Devilbiss 5L Compact Oxygen Concentrator (Model 525 Series) is not a sterile device. It is designed for reusable use in clinical and home settings, and sterility is not applicable to its operation. Proper cleaning and maintenance protocols must be followed to ensure hygiene and functionality.

• What are the key specifications for the Devilbiss 5L Compact Oxygen Concentrator?

  The device produces oxygen at flow rates up to 5 liters per minute with an oxygen purity range of 87% to 96%. It is classified under the FDA’s oxygen generator category and adheres to Class II medical device standards (regulation 868.5440). The compact design prioritizes portability and space efficiency, making it suitable for both clinical and home environments.

• How is the Devilbiss 5L Compact Oxygen Concentrator regulated?

  The Devilbiss 5L Compact Oxygen Concentrator (Model 525 Series) is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K071397. It is classified as substantially equivalent to predicate devices and falls under the Class II medical device category for oxygen generators. The device was reviewed by the Anesthesiology Advisory Committee and is manufactured in the United States.