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 / April 2026 / K252744

510(k) cleared

Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)

Cixi Ruihong Electric Appliance Co., Ltd. · Apr 3, 2026 · K252744

FDA cleared the Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) from Cixi Ruihong Electric Appliance Co., Ltd. on Apr 3, 2026 under K252744, 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 Aug 29, 2025. The decision came 217 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 Cixi Ruihong Electric Appliance Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252744?

K252744 is the FDA 510(k) for Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728), submitted by Cixi Ruihong Electric Appliance Co., Ltd.. FDA's decision date was Apr 3, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)?

Cixi Ruihong Electric Appliance Co., Ltd., based in Cixi, is the applicant of record for K252744.

How long did the K252744 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Apr 3, 2026, 217 days later.

← All decisions in April 2026