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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 / October 2025 / K252114

510(k) cleared

MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

Liofilchem s.r.l. · Oct 2, 2025 · K252114

FDA cleared the MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL from Liofilchem s.r.l. on Oct 2, 2025 under K252114, 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 7, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Liofilchem s.r.l. has 2 other decisions in the tracker over the last 12 months: K261853 (Gepotidacin GEP 10 µg), K260696 (MTS Gepotidacin 0.016-256 µg/mL).

Questions & Answers

What did FDA clear under K252114?

K252114 is the FDA 510(k) for MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL, submitted by Liofilchem s.r.l.. FDA's decision date was Oct 2, 2025, under product code JWY (Manual Antimicrobial Susceptibility Test Systems).

Who makes the MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL?

Liofilchem s.r.l., based in Roseto Degli Abruzzi, is the applicant of record for K252114.

How long did the K252114 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Oct 2, 2025, 87 days later.

← All decisions in October 2025

Sources