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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 / K262516

510(k) cleared

TSK OptiXion

Tsk Laboratory, Japan · Oct 6, 2026 · K262516

FDA cleared the TSK OptiXion from Tsk Laboratory, Japan on Oct 6, 2026 under K262516, a traditional 510(k). The device falls under product code QYM, Ophthalmic Needle, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 21, 2026. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Tsk Laboratory, Japan in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262516?

K262516 is the FDA 510(k) for TSK OptiXion, submitted by Tsk Laboratory, Japan. FDA's decision date was Oct 6, 2026, under product code QYM (Ophthalmic Needle).

Who makes the TSK OptiXion?

Tsk Laboratory, Japan, based in Tochigi-Ken, is the applicant of record for K262516.

How long did the K262516 review take?

FDA received the submission on Jul 21, 2026 and issued its decision on Oct 6, 2026, 77 days later.

← All decisions in October 2026