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FDA 510(k)

Hushd Pro Z-Link

K-Number: K251784 · 2025-10-24

ApplicantGood Sleep CO Pte , Ltd.
Decision Date2025-10-24
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Hushd Pro Z-Link is the device name listed in this FDA 510(k) record. The listed applicant is Good Sleep CO Pte , Ltd.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K251784. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hushd Pro Z-Link?

Hushd Pro Z-Link is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Good Sleep CO Pte , Ltd.. The 510(k) number is K251784.

When did Hushd Pro Z-Link receive FDA 510(k) clearance?

Hushd Pro Z-Link received FDA 510(k) clearance on 2025-10-24, under 510(k) number K251784.

Who is the listed applicant for Hushd Pro Z-Link?

The FDA 510(k) record lists Good Sleep CO Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hushd Pro Z-Link?

The FDA product code for Hushd Pro Z-Link is LRK.

Other records listing Good Sleep CO Pte , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252161Hushd AveraK232025Hushd Pro Avera

Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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