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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 / April 2026 / K253446

510(k) cleared

AeroDR TX c02

Dk Medical Systems Co., Ltd. · Apr 10, 2026 · K253446

FDA cleared the AeroDR TX c02 from Dk Medical Systems Co., Ltd. on Apr 10, 2026 under K253446, a traditional 510(k). The device falls under product code KPR, System, X-Ray, Stationary, regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Oct 2, 2025. The decision came 190 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Dk Medical Systems Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K253446?

K253446 is the FDA 510(k) for AeroDR TX c02, submitted by Dk Medical Systems Co., Ltd.. FDA's decision date was Apr 10, 2026, under product code KPR (System, X-Ray, Stationary).

Who makes the AeroDR TX c02?

Dk Medical Systems Co., Ltd., based in Pyeongtaek-Si, is the applicant of record for K253446.

How long did the K253446 review take?

FDA received the submission on Oct 2, 2025 and issued its decision on Apr 10, 2026, 190 days later.

← All decisions in April 2026