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The Tracker / September 2026 / K254289

510(k) cleared

Portable Oxygen Concentrator (OX-1A-E, OX-1B)

Oxytek Medical Technology Co., Ltd. · Sep 23, 2026 · K254289

FDA cleared the Portable Oxygen Concentrator (OX-1A-E, OX-1B) from Oxytek Medical Technology Co., Ltd. on Sep 23, 2026 under K254289, a traditional 510(k). The device falls under product code CAW, Generator, Oxygen, Portable, regulated at 21 CFR 868.5440 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Dec 31, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Oxytek Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252965 (Oxygen Concentrator (OX-5A, OX-5C)).

Questions & Answers

What did FDA clear under K254289?

K254289 is the FDA 510(k) for Portable Oxygen Concentrator (OX-1A-E, OX-1B), submitted by Oxytek Medical Technology Co., Ltd.. FDA's decision date was Sep 23, 2026, under product code CAW (Generator, Oxygen, Portable).

Who makes the Portable Oxygen Concentrator (OX-1A-E, OX-1B)?

Oxytek Medical Technology Co., Ltd., based in Chencun Town, Shunde District, Foshan, is the applicant of record for K254289.

How long did the K254289 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Sep 23, 2026, 266 days later.

← All decisions in September 2026

Sources