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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 / K260689

510(k) cleared

CVS Advanced PLUS Blood Glucose Monitoring System

I-Sens, Inc. · Oct 2, 2026 · K260689

FDA cleared the CVS Advanced PLUS Blood Glucose Monitoring System from I-Sens, Inc. on Oct 2, 2026 under K260689, a special 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 213 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K260689?

K260689 is the FDA 510(k) for CVS Advanced PLUS Blood Glucose Monitoring System, submitted by I-Sens, Inc.. FDA's decision date was Oct 2, 2026, under product code NBW (System, Test, Blood Glucose, Over The Counter).

Who makes the CVS Advanced PLUS Blood Glucose Monitoring System?

I-Sens, Inc., based in Seoul, is the applicant of record for K260689.

How long did the K260689 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on Oct 2, 2026, 213 days later.

← All decisions in October 2026