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 / K252540

510(k) cleared

ACCUJECT Injector Set 2.1-1P (LP604590)

Medicel AG · Sep 16, 2025 · K252540

FDA cleared the ACCUJECT Injector Set 2.1-1P (LP604590) from Medicel AG on Sep 16, 2025 under K252540, a traditional 510(k). The device falls under product code MSS, Folders And Injectors, Intraocular Lens (Iol), regulated at 21 CFR 886.4300 as a Class 1 device. The review panel was Ophthalmic.

FDA logged the submission as received on Aug 12, 2025. The decision came 35 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Medicel AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252540?

K252540 is the FDA 510(k) for ACCUJECT Injector Set 2.1-1P (LP604590), submitted by Medicel AG. FDA's decision date was Sep 16, 2025, under product code MSS (Folders And Injectors, Intraocular Lens (Iol)).

Who makes the ACCUJECT Injector Set 2.1-1P (LP604590)?

Medicel AG, based in Altenrhein, is the applicant of record for K252540.

How long did the K252540 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Sep 16, 2025, 35 days later.

← All decisions in September 2025