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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 / September 2025 / K252062

510(k) cleared

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL

Thermo Fisher Scientific · Sep 25, 2025 · K252062

FDA cleared the The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL from Thermo Fisher Scientific on Sep 25, 2025 under K252062, a traditional 510(k). The device falls under product code JWY, Manual Antimicrobial Susceptibility Test Systems, regulated at 21 CFR 866.1640 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jul 1, 2025. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

Thermo Fisher Scientific has 3 other decisions in the tracker over the last 12 months: K261781 (Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60), K251337 (Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10), 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 K252062?

K252062 is the FDA 510(k) for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL, submitted by Thermo Fisher Scientific. FDA's decision date was Sep 25, 2025, under product code JWY (Manual Antimicrobial Susceptibility Test Systems).

Who makes the The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL?

Thermo Fisher Scientific, based in Oakwood Village, OH, is the applicant of record for K252062.

How long did the K252062 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Sep 25, 2025, 86 days later.

← All decisions in September 2025