# K243752: Double Tube Herbst Appliance

- Pathway: 510(k) (Abbreviated)
- Applicant: The Tmj Clinic PC
- Decided: Sep 17, 2025 after 286 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K882303 (1989). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130130: Atg/SM-Osa Appliances, Selane Products, Inc. (2013)

## Indications for use
to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults

Source page: https://510kreport.com/device/K243752
Methodology: https://510kreport.com/methodology