← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LRK — Device, Anti-Snoring

DEVICE CLASS
Class II
REGULATION
21 CFR 872.5570
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
20
510(K)/PMA CLEARANCES
510k: 20
0
RECALL ENTRIES

Recent clearances

K261366Somnomed, Inc. · 510k2026-06-12
K261251Endeavor Commerce, LLC · 510k2026-06-11
K261134Koncept Innovators, Inc. · 510k2026-05-14
K252942Shaeferh, LLC · 510k2026-04-10
K253845Ram.Shaw Pte. , Ltd. · 510k2026-03-03
K252531Myofunctional Research Co. · 510k2026-03-02
K252976Park Dental Research Corp. · 510k2025-12-18
K253868QuietLab, LLC · 510k2025-12-05

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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