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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 2025 / K252376

510(k) cleared

Yomi S Robotic System

Neocis, Inc. · Oct 28, 2025 · K252376

FDA cleared the Yomi S Robotic System from Neocis, Inc. on Oct 28, 2025 under K252376, a traditional 510(k). The device falls under product code PLV, Dental Stereotaxic Instrument, regulated at 21 CFR 872.4120 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 30, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Neocis, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252376?

K252376 is the FDA 510(k) for Yomi S Robotic System, submitted by Neocis, Inc.. FDA's decision date was Oct 28, 2025, under product code PLV (Dental Stereotaxic Instrument).

Who makes the Yomi S Robotic System?

Neocis, Inc., based in Miami, FL, is the applicant of record for K252376.

How long did the K252376 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Oct 28, 2025, 90 days later.

← All decisions in October 2025