WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K260224

510(k) cleared

MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)

ImpediMed Limited · Aug 17, 2026 · K260224

FDA cleared the MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) from ImpediMed Limited on Aug 17, 2026 under K260224, a traditional 510(k). The device falls under product code DSB, Plethysmograph, Impedance, regulated at 21 CFR 870.2770 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 26, 2026. The decision came 203 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: K253224 (MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)).

Questions & Answers

What did FDA clear under K260224?

K260224 is the FDA 510(k) for MySOZO Software version 6.1.0.1 (SW version 6.1.0.1), submitted by ImpediMed Limited. FDA's decision date was Aug 17, 2026, under product code DSB (Plethysmograph, Impedance).

Who makes the MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)?

ImpediMed Limited, based in Lindfield, is the applicant of record for K260224.

How long did the K260224 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Aug 17, 2026, 203 days later.

← All decisions in August 2026

Sources