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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 / November 2025 / K252452

510(k) cleared

PeekMed web

Peek Health, S.A. · Nov 12, 2025 · K252452

FDA cleared the PeekMed web from Peek Health, S.A. on Nov 12, 2025 under K252452, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 4, 2025. The decision came 100 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Peek Health, S.A. has one other decision in the tracker over the last 12 months: K252856 (PeekMed web).

Questions & Answers

What did FDA clear under K252452?

K252452 is the FDA 510(k) for PeekMed web, submitted by Peek Health, S.A.. FDA's decision date was Nov 12, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the PeekMed web?

Peek Health, S.A., based in Braga, is the applicant of record for K252452.

How long did the K252452 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Nov 12, 2025, 100 days later.

← All decisions in November 2025

Sources