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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 / April 2026 / K252485

510(k) cleared

ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))

1987 Media Limited · Apr 10, 2026 · K252485

FDA cleared the ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) from 1987 Media Limited on Apr 10, 2026 under K252485, a traditional 510(k). The device falls under product code OBR, Mouthguard, Over-The-Counter as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Aug 7, 2025. The decision came 246 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 1987 Media Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252485?

K252485 is the FDA 510(k) for ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)), submitted by 1987 Media Limited. FDA's decision date was Apr 10, 2026, under product code OBR (Mouthguard, Over-The-Counter).

Who makes the ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))?

1987 Media Limited, based in Walton-On-Thames, is the applicant of record for K252485.

How long did the K252485 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Apr 10, 2026, 246 days later.

← All decisions in April 2026