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FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics 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 Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics 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 Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K261321

510(k) cleared

Yomi S Robotic System

Neocis, Inc. · Oct 13, 2026 · K261321

FDA cleared the Yomi S Robotic System from Neocis, Inc. on Oct 13, 2026 under K261321, a traditional 510(k). The device falls under product code QRY, Dental Navigation System, regulated at 21 CFR 872.4120 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 22, 2026. The decision came 174 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neocis, Inc. has one other decision in the tracker over the last 12 months: K252376 (Yomi S Robotic System).

Questions & Answers

What did FDA clear under K261321?

K261321 is the FDA 510(k) for Yomi S Robotic System, submitted by Neocis, Inc.. FDA's decision date was Oct 13, 2026, under product code QRY (Dental Navigation System).

Who makes the Yomi S Robotic System?

Neocis, Inc., based in Miami, FL, is the applicant of record for K261321.

How long did the K261321 review take?

FDA received the submission on Apr 22, 2026 and issued its decision on Oct 13, 2026, 174 days later.

← All decisions in October 2026