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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 / K252914

510(k) cleared

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

Hathor Professional Skincare , Ltd. · Jun 9, 2026 · K252914

FDA cleared the Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) from Hathor Professional Skincare , Ltd. on Jun 9, 2026 under K252914, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Sep 12, 2025. The decision came 270 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 Hathor Professional Skincare , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252914?

K252914 is the FDA 510(k) for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147), submitted by Hathor Professional Skincare , Ltd.. FDA's decision date was Jun 9, 2026, under product code NUC (Lubricant, Personal).

Who makes the Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

Hathor Professional Skincare , Ltd., based in Victoria, is the applicant of record for K252914.

How long did the K252914 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Jun 9, 2026, 270 days later.

← All decisions in June 2026