# K251784: Hushd Pro Z-Link

- Pathway: 510(k) (Traditional)
- Applicant: Good Sleep CO Pte, Ltd.
- Decided: Oct 24, 2025 after 135 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: 7 generations back to K882303 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232025: Hushd Pro Avera, Good Sleep CO Pte, Ltd. (2024) Summary page 5.

## Indications for use
The Hushd Pro Z-Link device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K251784
Methodology: https://510kreport.com/methodology