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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 / October 2025 / K252547

510(k) cleared

TheraSphere 360 Y-90 Management Platform

Boston Scientific Corporation · Oct 28, 2025 · K252547

FDA cleared the TheraSphere 360 Y-90 Management Platform from Boston Scientific Corporation on Oct 28, 2025 under K252547, 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 Aug 12, 2025. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K262151 (SpaceOAR Flex System), K262460 (Rezum System), K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance System).

Questions & Answers

What did FDA clear under K252547?

K252547 is the FDA 510(k) for TheraSphere 360 Y-90 Management Platform, submitted by Boston Scientific Corporation. FDA's decision date was Oct 28, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the TheraSphere 360 Y-90 Management Platform?

Boston Scientific Corporation, based in Marborough, MA, is the applicant of record for K252547.

How long did the K252547 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Oct 28, 2025, 77 days later.

← All decisions in October 2025