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FDA 510(k)

ShaeferH

K-Number: K252942 · 2026-04-10

ApplicantShaeferh, LLC
Decision Date2026-04-10
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ShaeferH is the device name listed in this FDA 510(k) record. The listed applicant is Shaeferh, LLC. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252942. 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 ShaeferH?

ShaeferH is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Shaeferh, LLC. The 510(k) number is K252942.

When did ShaeferH receive FDA 510(k) clearance?

ShaeferH received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252942.

Who is the listed applicant for ShaeferH?

The FDA 510(k) record lists Shaeferh, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ShaeferH?

The FDA product code for ShaeferH is LRK.

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.K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.

Official Source

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

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