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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 / November 2025 / K252521

510(k) cleared

LifeStyles® HydraFeel Natural Rubber Latex Condom

Suretex Limited · Nov 18, 2025 · K252521

FDA cleared the LifeStyles® HydraFeel Natural Rubber Latex Condom from Suretex Limited on Nov 18, 2025 under K252521, a abbreviated 510(k). The device falls under product code HIS, Condom, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Aug 11, 2025. The decision came 99 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 Suretex Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252521?

K252521 is the FDA 510(k) for LifeStyles® HydraFeel Natural Rubber Latex Condom, submitted by Suretex Limited. FDA's decision date was Nov 18, 2025, under product code HIS (Condom).

Who makes the LifeStyles® HydraFeel Natural Rubber Latex Condom?

Suretex Limited, based in Suratthani, is the applicant of record for K252521.

How long did the K252521 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Nov 18, 2025, 99 days later.

← All decisions in November 2025