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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 / K260687

510(k) cleared

VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.

Vivachek Biotech (Hangzhou) Co., Ltd. · Oct 9, 2026 · K260687

FDA cleared the VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. from Vivachek Biotech (Hangzhou) Co., Ltd. on Oct 9, 2026 under K260687, a traditional 510(k). The device falls under product code NBW, System, Test, Blood Glucose, Over The Counter, regulated at 21 CFR 862.1345 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Mar 3, 2026. The decision came 220 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Vivachek Biotech (Hangzhou) Co., Ltd. has one other decision in the tracker over the last 12 months: K261280 (BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel).

Questions & Answers

What did FDA clear under K260687?

K260687 is the FDA 510(k) for VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System., submitted by Vivachek Biotech (Hangzhou) Co., Ltd.. FDA's decision date was Oct 9, 2026, under product code NBW (System, Test, Blood Glucose, Over The Counter).

Who makes the VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.?

Vivachek Biotech (Hangzhou) Co., Ltd., based in Hangzhou, is the applicant of record for K260687.

How long did the K260687 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on Oct 9, 2026, 220 days later.

← All decisions in October 2026

Sources