WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / March 2026 / K260773

510(k) cleared

Varios Combi Pro2

Nakanishi, Inc. · Mar 10, 2026 · K260773

FDA cleared the Varios Combi Pro2 from Nakanishi, Inc. on Mar 10, 2026 under K260773, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code ELC, Scaler, Ultrasonic, regulated at 21 CFR 872.4850 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 9, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

Nakanishi, Inc. has one other decision in the tracker over the last 12 months: K254163 (VarioSurg 4).

Questions & Answers

What did FDA clear under K260773?

K260773 is the FDA 510(k) for Varios Combi Pro2, submitted by Nakanishi, Inc.. FDA's decision date was Mar 10, 2026, under product code ELC (Scaler, Ultrasonic).

Who makes the Varios Combi Pro2?

Nakanishi, Inc., based in Kanuma, is the applicant of record for K260773.

How long did the K260773 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Mar 10, 2026, 1 days later.

← All decisions in March 2026