WHERE ARE YOU?

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 / July 2026 / K261912

510(k) cleared

SnØreNegatØr

DnB Innovations, LLC · Jul 31, 2026 · K261912

FDA cleared the SnØreNegatØr from DnB Innovations, LLC on Jul 31, 2026 under K261912, a traditional 510(k). The device falls under product code LRK, Device, Anti-Snoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 8, 2026. The decision came 53 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for DnB Innovations, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261912?

K261912 is the FDA 510(k) for SnØreNegatØr, submitted by DnB Innovations, LLC. FDA's decision date was Jul 31, 2026, under product code LRK (Device, Anti-Snoring).

Who makes the SnØreNegatØr?

DnB Innovations, LLC, based in Keller, TX, is the applicant of record for K261912.

How long did the K261912 review take?

FDA received the submission on Jun 8, 2026 and issued its decision on Jul 31, 2026, 53 days later.

← All decisions in July 2026