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The Tracker / August 2026 / K262104

510(k) cleared

Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)

Ram.Shaw Pte., Ltd. · Aug 27, 2026 · K262104

FDA cleared the Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) from Ram.Shaw Pte., Ltd. on Aug 27, 2026 under K262104, a special 510(k). The device falls under product code LRK, Device, Anti-Snoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 23, 2026. The decision came 65 days later, inside the 90 FDA-day goal for a 510(k).

Ram.Shaw Pte., Ltd. has one other decision in the tracker over the last 12 months: K253845 (Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)).

Questions & Answers

What did FDA clear under K262104?

K262104 is the FDA 510(k) for Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT), submitted by Ram.Shaw Pte., Ltd.. FDA's decision date was Aug 27, 2026, under product code LRK (Device, Anti-Snoring).

Who makes the Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)?

Ram.Shaw Pte., Ltd., based in Singapore, is the applicant of record for K262104.

How long did the K262104 review take?

FDA received the submission on Jun 23, 2026 and issued its decision on Aug 27, 2026, 65 days later.

← All decisions in August 2026

Sources