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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 / September 2026 / K260619

510(k) cleared

VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL)

Biomérieux, Inc. · Sep 28, 2026 · K260619

FDA cleared the VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) from Biomérieux, Inc. on Sep 28, 2026 under K260619, a traditional 510(k). The device falls under product code LON, System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, regulated at 21 CFR 866.1645 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Feb 25, 2026. The decision came 215 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Biomérieux, Inc. has one other decision in the tracker over the last 12 months: K260447 (ETEST Gepotidacin (GEP) (0.016-256 µg/mL)).

Questions & Answers

What did FDA clear under K260619?

K260619 is the FDA 510(k) for VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL), submitted by Biomérieux, Inc.. FDA's decision date was Sep 28, 2026, under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation).

Who makes the VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL)?

Biomérieux, Inc., based in Hazelwood, MO, is the applicant of record for K260619.

How long did the K260619 review take?

FDA received the submission on Feb 25, 2026 and issued its decision on Sep 28, 2026, 215 days later.

← All decisions in September 2026

Sources