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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 / K253149

510(k) cleared

Motion InBra (YM-8801) wearable breast pump

Medela, LLC · Feb 13, 2026 · K253149

FDA cleared the Motion InBra (YM-8801) wearable breast pump from Medela, LLC on Feb 13, 2026 under K253149, 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 Sep 25, 2025. The decision came 141 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: K253510 (Freestyle Mini Hands-free), K253498 (Pump In Style® Pro+), K251377 (Magic InBra).

Questions & Answers

What did FDA clear under K253149?

K253149 is the FDA 510(k) for Motion InBra (YM-8801) wearable breast pump, submitted by Medela, LLC. FDA's decision date was Feb 13, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Motion InBra (YM-8801) wearable breast pump?

Medela, LLC, based in Mchenry, IL, is the applicant of record for K253149.

How long did the K253149 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Feb 13, 2026, 141 days later.

← All decisions in February 2026

Sources