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 / September 2025 / K251377

510(k) cleared

Magic InBra

Medela AG · Sep 18, 2025 · K251377

FDA cleared the Magic InBra from Medela AG on Sep 18, 2025 under K251377, 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 May 2, 2025. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medela AG has 3 other decisions in the tracker over the last 12 months: K253510 (Freestyle Mini Hands-free), K253149 (Motion InBra (YM-8801) wearable breast pump), K253498 (Pump In Style® Pro+).

Questions & Answers

What did FDA clear under K251377?

K251377 is the FDA 510(k) for Magic InBra, submitted by Medela AG. FDA's decision date was Sep 18, 2025, under product code HGX (Pump, Breast, Powered).

Who makes the Magic InBra?

Medela AG, based in Baar, is the applicant of record for K251377.

How long did the K251377 review take?

FDA received the submission on May 2, 2025 and issued its decision on Sep 18, 2025, 139 days later.

← All decisions in September 2025

Sources