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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 / December 2025 / K252120

510(k) cleared

Fundus On Phone Non Mydriatic (FOP NM-10)

Remidio Innovative Solutions Private Limited · Dec 12, 2025 · K252120

FDA cleared the Fundus On Phone Non Mydriatic (FOP NM-10) from Remidio Innovative Solutions Private Limited on Dec 12, 2025 under K252120, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code HKI, Camera, Ophthalmic, Ac-Powered, regulated at 21 CFR 886.1120 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jul 7, 2025. The decision came 158 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 Remidio Innovative Solutions Private Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252120?

K252120 is the FDA 510(k) for Fundus On Phone Non Mydriatic (FOP NM-10), submitted by Remidio Innovative Solutions Private Limited. FDA's decision date was Dec 12, 2025, under product code HKI (Camera, Ophthalmic, Ac-Powered).

Who makes the Fundus On Phone Non Mydriatic (FOP NM-10)?

Remidio Innovative Solutions Private Limited, based in Bengaluru, is the applicant of record for K252120.

How long did the K252120 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Dec 12, 2025, 158 days later.

← All decisions in December 2025