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 / K252525

510(k) cleared

AIO Breathe

Aiomega, LLC · Nov 6, 2025 · K252525

FDA cleared the AIO Breathe from Aiomega, LLC on Nov 6, 2025 under K252525, a abbreviated 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 11, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252525?

K252525 is the FDA 510(k) for AIO Breathe, submitted by Aiomega, LLC. FDA's decision date was Nov 6, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the AIO Breathe?

Aiomega, LLC, based in Tyler, TX, is the applicant of record for K252525.

How long did the K252525 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Nov 6, 2025, 87 days later.

← All decisions in November 2025