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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 / March 2026 / K252583

510(k) cleared

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)

A Cute Baby, Inc. · Mar 12, 2026 · K252583

FDA cleared the Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) from A Cute Baby, Inc. on Mar 12, 2026 under K252583, a abbreviated 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 Aug 15, 2025. The decision came 209 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 A Cute Baby, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252583?

K252583 is the FDA 510(k) for Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220), submitted by A Cute Baby, Inc.. FDA's decision date was Mar 12, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)?

A Cute Baby, Inc., based in Orem, UT, is the applicant of record for K252583.

How long did the K252583 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Mar 12, 2026, 209 days later.

← All decisions in March 2026