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 / November 2025 / K252698

510(k) cleared

NightGuard Aire Max

Nightguard Express, LLC · Nov 3, 2025 · K252698

FDA cleared the NightGuard Aire Max from Nightguard Express, LLC on Nov 3, 2025 under K252698, 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 Aug 27, 2025. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252698?

K252698 is the FDA 510(k) for NightGuard Aire Max, submitted by Nightguard Express, LLC. FDA's decision date was Nov 3, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the NightGuard Aire Max?

Nightguard Express, LLC, based in Lewisville, TX, is the applicant of record for K252698.

How long did the K252698 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Nov 3, 2025, 68 days later.

← All decisions in November 2025