# K170053: Meridian PM

- Pathway: 510(k) (Abbreviated)
- Applicant: The Center For Craniofacial & Dental Sleep Medicine
- Decided: Nov 28, 2017 after 327 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: 6 generations back to K882303 (1989). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153291: Sicat Optisleep, Sicat GmbH & Co. KG (2016) Summary page 5.
- K113516: Therasom-Cast, Family Dental Services, P.C. (2013) Summary page 5.

## Indications for use
The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K170053
Methodology: https://510kreport.com/methodology