Yuyue OxygenMax Oxygen Concentrator, Models 7F-5A/7F-5B

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Model / Reference

8F-5A, 8F-10

Primary DI / UDI-DI

06933257921924, 06933257924451

Basic UDI-DI

693325792192J8, 693325792445JE

Direct Marketing DI

06933257921924

06933257924451

510(k) Number

K083559 ↗

FDA Product Code

CAW

EMDN Code

Z12159004 Oxygen concentrators

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 868.5440

EU market of registration

Greece

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Electronic blood pressure monitor

  Class IIa

  CE/MDR

• oxygen concentrator

  Class IIb

  CE/MDR

• YUWELL® Finger Pulse Oximeter

  Class IIa

  CE/MDR

• Probe cover

  Class IIa

  CE/MDR

• Nebulizing Mesh

  Class I

  CE/MDR

• Infrared ear thermometer

  Class IIa

  CE/MDR

See all devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. →

• What clinical specialties is this device primarily intended for according to its regulatory filings?

  The Yuyue OxygenMax Oxygen Concentrator (Models 7F-5A/7F-5B) is specifically associated with the anesthesiology specialty in its regulatory filings. This indicates its primary use is in clinical settings where oxygen therapy is critical, such as during surgical procedures or anesthesia administration, though its broader application in other oxygen-dependent scenarios cannot be excluded without additional context.

• Is this device single-use or reusable, and what does that mean for maintenance and cleaning?

  The Yuyue OxygenMax Oxygen Concentrator is designed as a reusable medical instrument, meaning it is intended for repeated use across multiple patients. Since it does not require sterilization between uses, maintenance follows manufacturer guidelines to ensure proper functionality and safety. This includes regular cleaning and servicing to prevent contamination or mechanical failure, though specific protocols are not detailed in the provided data.

• Can this device be used in an MRI environment, and why or why not?

  No, the Yuyue OxygenMax Oxygen Concentrator is not intended for use in MRI environments. The device description explicitly states it is unsuitable for such settings, likely due to potential electromagnetic interference or safety risks associated with magnetic resonance imaging. Always verify compatibility with facility-specific MRI protocols before use.

• What regulatory pathways has this device undergone, and what does that imply for its approval status?

  The Yuyue OxygenMax Oxygen Concentrator has undergone FDA 510(k) clearance and EU MDR compliance, as indicated by the provided data. The FDA clearance (K083559) under the Anesthesiology Advisory Committee confirms it is classified as a Class II device and deemed substantially equivalent to a predicate device. The EU MDR compliance suggests it meets European Union regulatory requirements for medical devices, though specific approval statuses (e.g., CE marking) are not explicitly stated in the data.

• Are there multiple models available, and how do they differ in terms of regulatory or functional specifications?

  Yes, there are two models: 7F-5A and 7F-5B. While the provided data does not specify functional differences between these models, both share the same FDA 510(k) clearance (K083559) and EU MDR compliance, implying they meet identical regulatory standards. Any distinctions would likely relate to design, performance, or features not explicitly detailed in the summary, such as portability, flow rates, or additional clinical functionalities.