FDA Product Code KRH: Ring, Annuloplasty
Annuloplasty rings restore mitral valve geometry and competence in mitral regurgitation surgery. FDA product code KRH covers annuloplasty rings used in heart valve repair.
These rigid or flexible rings are sewn to the mitral or tricuspid annulus to reduce annular diameter, restore the normal saddle-shaped geometry, and support the valve leaflets, enabling durable repair of regurgitant valves while preserving native valve tissue.
KRH devices are Class II medical devices, regulated under 21 CFR 870.3800 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Genesee Biomedical, Inc., Edwards Lifesciences, LLC and Abbott Medical.
FDA 510(k) Cleared Ring, Annuloplasty Devices (Product Code KRH)
About Product Code KRH - Regulatory Context
510(k) Submission Activity
74 total 510(k) submissions under product code KRH since 1979, with 72 receiving FDA clearance (average review time: 103 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KRH have taken an average of 82 days to reach a decision - down from 104 days historically, suggesting improved FDA processing for this classification.
KRH devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →