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 / December 2025 / K251881

510(k) cleared

HippoMind (v1.0)

Hippoclinic · Dec 3, 2025 · K251881

FDA cleared the HippoMind (v1.0) from Hippoclinic on Dec 3, 2025 under K251881, a traditional 510(k). The device falls under product code OLT, Non-Normalizing Quantitative Electroencephalograph Software, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 18, 2025. The decision came 168 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 Hippoclinic in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251881?

K251881 is the FDA 510(k) for HippoMind (v1.0), submitted by Hippoclinic. FDA's decision date was Dec 3, 2025, under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software).

Who makes the HippoMind (v1.0)?

Hippoclinic, based in Mountain View, CA, is the applicant of record for K251881.

How long did the K251881 review take?

FDA received the submission on Jun 18, 2025 and issued its decision on Dec 3, 2025, 168 days later.

← All decisions in December 2025