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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 / December 2025 / K253719

510(k) cleared

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons

Unibeauty (Hubei) Technology Co., Ltd. · Dec 17, 2025 · K253719

FDA cleared the Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons from Unibeauty (Hubei) Technology Co., Ltd. on Dec 17, 2025 under K253719, 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 Nov 24, 2025. The decision came 23 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: K252613 (Unscented menstrual three-piece applicator tampon).

Questions & Answers

What did FDA clear under K253719?

K253719 is the FDA 510(k) for Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons, submitted by Unibeauty (Hubei) Technology Co., Ltd.. FDA's decision date was Dec 17, 2025, under product code HEB (Tampon, Menstrual, Unscented).

Who makes the Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons?

Unibeauty (Hubei) Technology Co., Ltd., based in Xiantao, is the applicant of record for K253719.

How long did the K253719 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Dec 17, 2025, 23 days later.

← All decisions in December 2025

Sources