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 / September 2025 / K243752

510(k) cleared

Double Tube Herbst Appliance

The Tmj Clinic PC · Sep 17, 2025 · K243752

FDA cleared the Double Tube Herbst Appliance from The Tmj Clinic PC on Sep 17, 2025 under K243752, 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 Dec 5, 2024. The decision came 286 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 The Tmj Clinic PC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243752?

K243752 is the FDA 510(k) for Double Tube Herbst Appliance, submitted by The Tmj Clinic PC. FDA's decision date was Sep 17, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the Double Tube Herbst Appliance?

The Tmj Clinic PC, based in Portland, OR, is the applicant of record for K243752.

How long did the K243752 review take?

FDA received the submission on Dec 5, 2024 and issued its decision on Sep 17, 2025, 286 days later.

← All decisions in September 2025