FDA Product Code QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
A Disposable Blood Lancet Intended For A Single Use That Is Comprised Of A Single Use Blade Attached To A Solid, Nonreusable Base That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes.
Leading manufacturers include Ningbo Medsun Medical Co., Ltd., Ascensia Diabetes Care U.S., Inc. and Ningbo Caremed Medical Products Co., Ltd..
FDA 510(k) Cleared Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature Devices (Product Code QRK)
About Product Code QRK - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code QRK since 2022, with 15 receiving FDA clearance (average review time: 118 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 11 in the prior period.
FDA Review Time
Recent submissions under QRK have taken an average of 87 days to reach a decision - down from 129 days historically, suggesting improved FDA processing for this classification.
QRK devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →