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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 / December 2025 / K251337

510(k) cleared

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

Thermo Fisher Scientific (Oxoid Ltd.) · Dec 5, 2025 · K251337

FDA cleared the Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 from Thermo Fisher Scientific (Oxoid Ltd.) on Dec 5, 2025 under K251337, 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 Apr 30, 2025. The decision came 219 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Thermo Fisher Scientific (Oxoid Ltd.) has 3 other decisions in the tracker over the last 12 months: K261781 (Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60), 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 K251337?

K251337 is the FDA 510(k) for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10, submitted by Thermo Fisher Scientific (Oxoid Ltd.). FDA's decision date was Dec 5, 2025, under product code JTN (Susceptibility Test Discs, Antimicrobial).

Who makes the Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10?

Thermo Fisher Scientific (Oxoid Ltd.), based in Basingstoke, is the applicant of record for K251337.

How long did the K251337 review take?

FDA received the submission on Apr 30, 2025 and issued its decision on Dec 5, 2025, 219 days later.

← All decisions in December 2025