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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 / February 2026 / K260119

510(k) cleared

SpaceOAR Vue System (SV-2101)

Boston Scientific Corporation · Feb 10, 2026 · K260119

FDA cleared the SpaceOAR Vue System (SV-2101) from Boston Scientific Corporation on Feb 10, 2026 under K260119, a special 510(k). The device falls under product code OVB, Hydrogel Spacer, regulated at 21 CFR 892.5725 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 14, 2026. The decision came 27 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 K260119?

K260119 is the FDA 510(k) for SpaceOAR Vue System (SV-2101), submitted by Boston Scientific Corporation. FDA's decision date was Feb 10, 2026, under product code OVB (Hydrogel Spacer).

Who makes the SpaceOAR Vue System (SV-2101)?

Boston Scientific Corporation, based in Marborough, MA, is the applicant of record for K260119.

How long did the K260119 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Feb 10, 2026, 27 days later.

← All decisions in February 2026