# K190051: TD Clip

- Pathway: 510(k) (Abbreviated)
- Applicant: Zephyr Sleep Technologies, Inc.
- Decided: Jun 7, 2019 after 147 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: 8 generations back to K882303 (1989). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111110: Apnea Guard, Advanced Brain Monitoring, Inc. (2011) Summary page 4.

## Indications for use
The TD Clip is intended to be used with MATRx or MATRx plus Titration Trays to form a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The device is intended to be fitted with assistance from a healthcare professional and used during sleep for a total of less than 30 nights.

Source page: https://510kreport.com/device/K190051
Methodology: https://510kreport.com/methodology