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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 / July 2026 / K261781

510(k) cleared

Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60

Thermo Fisher Scientific (Oxoid Ltd.) · Jul 24, 2026 · K261781

FDA cleared the Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 from Thermo Fisher Scientific (Oxoid Ltd.) on Jul 24, 2026 under K261781, a traditional 510(k). The device falls under product code JTN, Susceptibility Test Discs, Antimicrobial, regulated at 21 CFR 866.1620 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on May 29, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Thermo Fisher Scientific (Oxoid Ltd.) has one other decision in the tracker over the last 12 months: K251337 (Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10).

Questions & Answers

What did FDA clear under K261781?

K261781 is the FDA 510(k) for Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60, submitted by Thermo Fisher Scientific (Oxoid Ltd.). FDA's decision date was Jul 24, 2026, under product code JTN (Susceptibility Test Discs, Antimicrobial).

Who makes the Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60?

Thermo Fisher Scientific (Oxoid Ltd.), based in Basingstoke, is the applicant of record for K261781.

How long did the K261781 review take?

FDA received the submission on May 29, 2026 and issued its decision on Jul 24, 2026, 56 days later.

← All decisions in July 2026

Sources