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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 / K251320

510(k) cleared

XTRA4

Al.Chi.Mi.A. S.R.L · Sep 11, 2025 · K251320

FDA cleared the XTRA4 from Al.Chi.Mi.A. S.R.L on Sep 11, 2025 under K251320, a traditional 510(k). The device falls under product code LYX, Media, Corneal Storage as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 29, 2025. The decision came 135 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Al.Chi.Mi.A. S.R.L in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251320?

K251320 is the FDA 510(k) for XTRA4, submitted by Al.Chi.Mi.A. S.R.L. FDA's decision date was Sep 11, 2025, under product code LYX (Media, Corneal Storage).

Who makes the XTRA4?

Al.Chi.Mi.A. S.R.L, based in Ponte San Nicolò, is the applicant of record for K251320.

How long did the K251320 review take?

FDA received the submission on Apr 29, 2025 and issued its decision on Sep 11, 2025, 135 days later.

← All decisions in September 2025