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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 / K261500

510(k) cleared

KBA3D (v2.4.0)

S.M.A.I.O · Aug 17, 2026 · K261500

FDA cleared the KBA3D (v2.4.0) from S.M.A.I.O on Aug 17, 2026 under K261500, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 6, 2026. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

S.M.A.I.O has 8 other decisions in the tracker over the last 12 months: DEN250043 (Qoramatic Automated Stool Management), K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System).

Questions & Answers

What did FDA clear under K261500?

K261500 is the FDA 510(k) for KBA3D (v2.4.0), submitted by S.M.A.I.O. FDA's decision date was Aug 17, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the KBA3D (v2.4.0)?

S.M.A.I.O, based in Saint-Priest, is the applicant of record for K261500.

How long did the K261500 review take?

FDA received the submission on May 6, 2026 and issued its decision on Aug 17, 2026, 103 days later.

← All decisions in August 2026