Devo/MC44 Oxygen Concentrator
by The Devilbiss Co. 510(k)
Active
510(k) K872470
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872470 | Date3 Aug 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5440
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DeVO MC44 Oxygen Concentrator is a portable oxygen generator classified as a medical gas generator. It is designed to separate oxygen from ambient air, delivering concentrated oxygen for therapeutic use in both home and institutional settings. The device operates by compressing and purifying air to produce oxygen concentrations of 95% ± 3% at a flow rate of 1–5 liters per minute, suitable for patients requiring supplemental oxygen therapy.
This device is intended for single-use or reusable applications in clinical environments, depending on manufacturer guidelines. It is not MRI-safe and must be used in non-magnetic areas. Supplied as a standalone unit, the DeVO MC44 requires proper storage in a clean, dry environment to maintain functionality. Authorized for use under FDA 510(k) clearance (K872470), it adheres to regulatory standards for Class II medical devices under the FDA’s oxygen generator classification (21 CFR 868.5440).
Other devices from The Devilbiss Co.
Questions
AI-generated answers, 1 Oct 2026
What is the DeVO MC44 Oxygen Concentrator used for?
The DeVO MC44 is a portable oxygen generator designed to separate oxygen from ambient air and deliver concentrated oxygen for therapeutic use. It is intended for patients requiring supplemental oxygen therapy in both home and institutional settings, providing a flow rate of 1–5 liters per minute with an oxygen concentration of 95% ± 3%. This makes it suitable for continuous or intermittent oxygen support in clinical environments where portable oxygen delivery is needed.
Is the DeVO MC44 single-use or reusable?
The DeVO MC44 can be used in either single-use or reusable applications, depending on the manufacturer’s guidelines for the specific clinical setting. Reuse requires adherence to cleaning and maintenance protocols to ensure safety and performance. Always follow the manufacturer’s instructions to determine the appropriate use case for your facility.
Where should the DeVO MC44 be stored?
The DeVO MC44 should be stored in a clean, dry environment to maintain its functionality and ensure longevity. Avoid exposure to moisture, extreme temperatures, or magnetic fields, as these can affect performance. Since it is not MRI-safe, it must be kept in non-magnetic areas when not in use.
What are the key specifications of the DeVO MC44?
The DeVO MC44 delivers oxygen at a concentration of 95% ± 3% with a flow rate adjustable between 1 and 5 liters per minute. It operates by compressing and purifying ambient air, making it a portable solution for supplemental oxygen therapy. The device is FDA-cleared under 510(k) clearance (K872470) and classified as a Class II medical device under 21 CFR 868.5440.
Can the DeVO MC44 be used in an MRI environment?
No, the DeVO MC44 is not MRI-safe and must be used in non-magnetic areas only. Exposure to magnetic fields could compromise the device’s functionality or pose safety risks. Always ensure the device is placed outside MRI zones to prevent interference or damage.