WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K250575

510(k) cleared

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

Thermo Fisher Scientific · Sep 5, 2025 · K250575

FDA cleared the 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 from Thermo Fisher Scientific on Sep 5, 2025 under K250575, 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 Feb 26, 2025. The decision came 191 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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), K252062 (The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL).

Questions & Answers

What did FDA clear under K250575?

K250575 is the FDA 510(k) for 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, submitted by Thermo Fisher Scientific. FDA's decision date was Sep 5, 2025, under product code JWY (Manual Antimicrobial Susceptibility Test Systems).

Who makes the 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?

Thermo Fisher Scientific, based in Oakwood Village, OH, is the applicant of record for K250575.

How long did the K250575 review take?

FDA received the submission on Feb 26, 2025 and issued its decision on Sep 5, 2025, 191 days later.

← All decisions in September 2025

Sources