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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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.

This is the only decision on file for ImpediMed Limited in the last 12 months of the tracker.

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