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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 2026 / K260096

510(k) cleared

Wishbone HAE

Wishbone SA · Oct 9, 2026 · K260096

FDA cleared the Wishbone HAE from Wishbone SA on Oct 9, 2026 under K260096, a traditional 510(k). The device falls under product code NPM, Bone Grafting Material, Animal Source, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jan 13, 2026. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Wishbone SA in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260096?

K260096 is the FDA 510(k) for Wishbone HAE, submitted by Wishbone SA. FDA's decision date was Oct 9, 2026, under product code NPM (Bone Grafting Material, Animal Source).

Who makes the Wishbone HAE?

Wishbone SA, based in Flémalle, is the applicant of record for K260096.

How long did the K260096 review take?

FDA received the submission on Jan 13, 2026 and issued its decision on Oct 9, 2026, 269 days later.

← All decisions in October 2026