FDA Product Code QRL: Multiple Use Blood Lancet For Single Patient Use Only
Repeated blood sampling is essential in diabetes management and chronic disease monitoring. FDA product code QRL covers multiple-use capable blood lancets intended for single-patient use over multiple sessions.
Unlike strictly single-use lancets, these devices are designed to allow the same patient to reuse the lancet across multiple lancing events for capillary blood sampling, reducing waste and cost in patients requiring frequent glucose monitoring or other point-of-care testing.
QRL devices are Class II medical devices, regulated under 21 CFR 878.4850 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Tianjin Huahong Technology Co., Ltd., Bionime Corporation and I-Sens, Inc..
FDA 510(k) Cleared Multiple Use Blood Lancet For Single Patient Use Only Devices (Product Code QRL)
About Product Code QRL - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code QRL since 2022, with 24 receiving FDA clearance (average review time: 106 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 19 in the prior period.
FDA Review Time
Recent submissions under QRL have taken an average of 33 days to reach a decision - down from 117 days historically, suggesting improved FDA processing for this classification.
QRL devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →