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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 / July 2026 / K253704

510(k) cleared

iPredict-DR

iHealthscreen, Inc. · Jul 2, 2026 · K253704

FDA cleared the iPredict-DR from iHealthscreen, Inc. on Jul 2, 2026 under K253704, a traditional 510(k). The device falls under product code PIB, Diabetic Retinopathy Detection Device, regulated at 21 CFR 886.1100 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Nov 24, 2025. The decision came 220 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 iHealthscreen, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253704?

K253704 is the FDA 510(k) for iPredict-DR, submitted by iHealthscreen, Inc.. FDA's decision date was Jul 2, 2026, under product code PIB (Diabetic Retinopathy Detection Device).

Who makes the iPredict-DR?

iHealthscreen, Inc., based in Richmond Hill, NY, is the applicant of record for K253704.

How long did the K253704 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jul 2, 2026, 220 days later.

← All decisions in July 2026