Portable oxygen concentrator (JLO-190P)

FDA 510(k) K252616 · Shenzhen Homed Medical Device Co., Ltd.

Substantially Equivalent

510(k) numberK252616

Submission

Device name
Portable oxygen concentrator (JLO-190P)
Applicant
Shenzhen Homed Medical Device Co., Ltd.
Shenzhen, CN
Received
August 19, 2025
Decision date
December 22, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAW – Generator, Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5440
Specialty
Anesthesiology

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K251607Oxygen Concentrator (J5A)CAW · Traditional Foshan Kycare Medical Equipment Co., Ltd.11/21/2025SE

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Questions and answers

When was Portable oxygen concentrator (JLO-190P) cleared by the FDA?

Portable oxygen concentrator (JLO-190P) (K252616) received a 510(k) decision of Substantially Equivalent on December 22, 2025, 125 days after the submission was received.

What is the product code of K252616?

The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.