Cleared Traditional

Hushd Pro Z-Link

K251784 · Good Sleep CO Pte , Ltd. · Dental

Oct 2025

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K251784 is an FDA 510(k) clearance for the Hushd Pro Z-Link, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Good Sleep CO Pte , Ltd. (Singapore, SG). The FDA issued a Cleared decision on October 24, 2025, 135 days after receiving the submission on June 11, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K251784 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2025
Decision Date	October 24, 2025
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF