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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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 3 other decisions in the tracker over the last 12 months: K251337 (Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10), K252062 (The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL), K250575 (The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL).

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