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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 / January 2026 / K253224

510(k) cleared

MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)

ImpediMed Limited · Jan 28, 2026 · K253224

FDA cleared the MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) from ImpediMed Limited on Jan 28, 2026 under K253224, a traditional 510(k). The device falls under product code OBH, Monitor, Extracellular Fluid, Lymphedema, Extremity, regulated at 21 CFR 870.2770 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 29, 2025. The decision came 121 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ImpediMed Limited has one other decision in the tracker over the last 12 months: K260224 (MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)).

Questions & Answers

What did FDA clear under K253224?

K253224 is the FDA 510(k) for MySOZO Software version 6.0.1.2 (SW version 6.0.1.2), submitted by ImpediMed Limited. FDA's decision date was Jan 28, 2026, under product code OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity).

Who makes the MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)?

ImpediMed Limited, based in Pinkenba, is the applicant of record for K253224.

How long did the K253224 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jan 28, 2026, 121 days later.

← All decisions in January 2026

Sources