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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 / January 2026 / K253511

510(k) cleared

Concerto Versa Detachable Coil

Medtronic, Inc. · Jan 14, 2026 · K253511

FDA cleared the Concerto Versa Detachable Coil from Medtronic, Inc. on Jan 14, 2026 under K253511, a traditional 510(k). The device falls under product code KRD, Device, Vascular, For Promoting Embolization, regulated at 21 CFR 870.3300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 5, 2025. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K262913 (Protégé EverFlex Self-expanding Peripheral Stent System), K262735 (LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)), K262005 (Affera Integrated Mapping System), K261335 (VitalFlow Set with Balance Biosurface).

Questions & Answers

What did FDA clear under K253511?

K253511 is the FDA 510(k) for Concerto Versa Detachable Coil, submitted by Medtronic, Inc.. FDA's decision date was Jan 14, 2026, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the Concerto Versa Detachable Coil?

Medtronic, Inc., based in Plymouth, MN, is the applicant of record for K253511.

How long did the K253511 review take?

FDA received the submission on Nov 5, 2025 and issued its decision on Jan 14, 2026, 70 days later.

← All decisions in January 2026