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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 / February 2026 / K252751

510(k) cleared

Earflo (EF001)

Earflo, Inc. · Feb 10, 2026 · K252751

FDA cleared the Earflo (EF001) from Earflo, Inc. on Feb 10, 2026 under K252751, a traditional 510(k). The device falls under product code MJV, Device, Inflation, Middle Ear as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Aug 29, 2025. The decision came 165 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 Earflo, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252751?

K252751 is the FDA 510(k) for Earflo (EF001), submitted by Earflo, Inc.. FDA's decision date was Feb 10, 2026, under product code MJV (Device, Inflation, Middle Ear).

Who makes the Earflo (EF001)?

Earflo, Inc., based in San Carlos, CA, is the applicant of record for K252751.

How long did the K252751 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Feb 10, 2026, 165 days later.

← All decisions in February 2026