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FDA 510(k)

Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)

K-Number: K253845 · 2026-03-03

ApplicantRam.Shaw Pte. , Ltd.
Decision Date2026-03-03
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) is the device name listed in this FDA 510(k) record. The listed applicant is Ram.Shaw Pte. , Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253845. 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 Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)?

Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Ram.Shaw Pte. , Ltd.. The 510(k) number is K253845.

When did Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) receive FDA 510(k) clearance?

Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K253845.

Who is the listed applicant for Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)?

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

What is the FDA product code for Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)?

The FDA product code for Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) 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.K252942ShaeferHShaeferh, LLCK252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.

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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