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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 / September 2025 / K252613

510(k) cleared

Unscented menstrual three-piece applicator tampon

Unibeauty (Hubei) Technology Co., Ltd. · Sep 19, 2025 · K252613

FDA cleared the Unscented menstrual three-piece applicator tampon from Unibeauty (Hubei) Technology Co., Ltd. on Sep 19, 2025 under K252613, a special 510(k). The device falls under product code HEB, Tampon, Menstrual, Unscented, regulated at 21 CFR 884.5470 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Aug 19, 2025. The decision came 31 days later, inside the 90 FDA-day goal for a 510(k).

Unibeauty (Hubei) Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253719 (Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons).

Questions & Answers

What did FDA clear under K252613?

K252613 is the FDA 510(k) for Unscented menstrual three-piece applicator tampon, submitted by Unibeauty (Hubei) Technology Co., Ltd.. FDA's decision date was Sep 19, 2025, under product code HEB (Tampon, Menstrual, Unscented).

Who makes the Unscented menstrual three-piece applicator tampon?

Unibeauty (Hubei) Technology Co., Ltd., based in Xiantao, is the applicant of record for K252613.

How long did the K252613 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on Sep 19, 2025, 31 days later.

← All decisions in September 2025

Sources