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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 / April 2026 / K253510

510(k) cleared

Freestyle Mini Hands-free

Medela, LLC · Apr 10, 2026 · K253510

FDA cleared the Freestyle Mini Hands-free from Medela, LLC on Apr 10, 2026 under K253510, a traditional 510(k). The device falls under product code HGX, Pump, Breast, Powered, regulated at 21 CFR 884.5160 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Nov 5, 2025. The decision came 156 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medela, LLC has 3 other decisions in the tracker over the last 12 months: K253149 (Motion InBra (YM-8801) wearable breast pump), K253498 (Pump In Style® Pro+), K251377 (Magic InBra).

Questions & Answers

What did FDA clear under K253510?

K253510 is the FDA 510(k) for Freestyle Mini Hands-free, submitted by Medela, LLC. FDA's decision date was Apr 10, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Freestyle Mini Hands-free?

Medela, LLC, based in Mchenry, IL, is the applicant of record for K253510.

How long did the K253510 review take?

FDA received the submission on Nov 5, 2025 and issued its decision on Apr 10, 2026, 156 days later.

← All decisions in April 2026

Sources