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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 / January 2026 / K253498

510(k) cleared

Pump In Style® Pro+

Medela, LLC · Jan 22, 2026 · K253498

FDA cleared the Pump In Style® Pro+ from Medela, LLC on Jan 22, 2026 under K253498, a special 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 Oct 29, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Medela, LLC 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), K251377 (Magic InBra).

Questions & Answers

What did FDA clear under K253498?

K253498 is the FDA 510(k) for Pump In Style® Pro+, submitted by Medela, LLC. FDA's decision date was Jan 22, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Pump In Style® Pro+?

Medela, LLC, based in Mchenry, IL, is the applicant of record for K253498.

How long did the K253498 review take?

FDA received the submission on Oct 29, 2025 and issued its decision on Jan 22, 2026, 85 days later.

← All decisions in January 2026

Sources