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FDA 510(k)

Hushd Avera

K-Number: K252161 · 2025-11-25

ApplicantGood Sleep CO Pte , Ltd.
Decision Date2025-11-25
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Hushd Avera 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 2025-11-25 under 510(k) number K252161. 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 Avera?

Hushd Avera is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Good Sleep CO Pte , Ltd.. The 510(k) number is K252161.

When did Hushd Avera receive FDA 510(k) clearance?

Hushd Avera received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252161.

Who is the listed applicant for Hushd Avera?

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 Avera?

The FDA product code for Hushd Avera 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.

K251784Hushd Pro Z-LinkK232025Hushd 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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