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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / May 2026 / K252965

510(k) cleared

Oxygen Concentrator (OX-5A, OX-5C)

Oxytek Medical Technology Co., Ltd. · May 29, 2026 · K252965

FDA cleared the Oxygen Concentrator (OX-5A, OX-5C) from Oxytek Medical Technology Co., Ltd. on May 29, 2026 under K252965, 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 Sep 17, 2025. The decision came 254 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: K254289 (Portable Oxygen Concentrator (OX-1A-E, OX-1B)).

Questions & Answers

What did FDA clear under K252965?

K252965 is the FDA 510(k) for Oxygen Concentrator (OX-5A, OX-5C), submitted by Oxytek Medical Technology Co., Ltd.. FDA's decision date was May 29, 2026, under product code CAW (Generator, Oxygen, Portable).

Who makes the Oxygen Concentrator (OX-5A, OX-5C)?

Oxytek Medical Technology Co., Ltd., based in Chencun Town, Shunde District, Foshan, is the applicant of record for K252965.

How long did the K252965 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on May 29, 2026, 254 days later.

← All decisions in May 2026

Sources