RX02 Plus Oxygen Concentrator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K860060 ↗

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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• Arizona Oxygen Timer Device

  Class I

  FDA 510(k) K761260 Active Cleared 16 Dec 1976

• Bunn Model 510 Medication Compressor

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• John Bunn: Medix Compact Traveller

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See all devices from The John Bunn Co. →

• What is the Rx02 Plus Oxygen Concentrator used for?

  The Rx02 Plus Oxygen Concentrator is intended to generate oxygen for therapeutic use by producing oxygen-enriched air from ambient air, making it suitable for patients requiring supplemental oxygen in healthcare environments.

• Is the Rx02 Plus Oxygen Concentrator reusable or single-use?

  The device is supplied as a reusable unit designed for repeated use in healthcare settings, not as a single-use disposable product, allowing for ongoing operation after proper maintenance and cleaning.

• What regulatory pathway was used for the Rx02 Plus Oxygen Concentrator?

  The Rx02 Plus Oxygen Concentrator received FDA 510(k) clearance under submission K860060, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under regulation 868.5440 with product code CAW.