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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 / K260283

510(k) cleared

VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)

bioMerieux, Inc. · Oct 1, 2026 · K260283

FDA cleared the VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) from bioMerieux, Inc. on Oct 1, 2026 under K260283, 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 Jan 29, 2026. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

bioMerieux, Inc. has 3 other decisions in the tracker over the last 12 months: K260160 (VITEK REVEAL GN AST Assay and VITEK REVEAL AST System), K260282 (VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance), K260281 (VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)).

Questions & Answers

What did FDA clear under K260283?

K260283 is the FDA 510(k) for VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL), submitted by bioMerieux, Inc.. FDA's decision date was Oct 1, 2026, under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation).

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

bioMerieux, Inc., based in Hazelwood, MO, is the applicant of record for K260283.

How long did the K260283 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Oct 1, 2026, 245 days later.

← All decisions in October 2026

Sources