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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 / June 2026 / K250129

510(k) cleared

AViTA Breast Pump

Avita Corporation · Jun 11, 2026 · K250129

FDA cleared the AViTA Breast Pump from Avita Corporation on Jun 11, 2026 under K250129, 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 Jan 17, 2025. The decision came 510 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Avita Corporation has one other decision in the tracker over the last 12 months: K252448 (AViTA Pulse Oximeter (SP61)).

Questions & Answers

What did FDA clear under K250129?

K250129 is the FDA 510(k) for AViTA Breast Pump, submitted by Avita Corporation. FDA's decision date was Jun 11, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the AViTA Breast Pump?

Avita Corporation, based in New Taipei City, is the applicant of record for K250129.

How long did the K250129 review take?

FDA received the submission on Jan 17, 2025 and issued its decision on Jun 11, 2026, 510 days later.

← All decisions in June 2026

Sources