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 Bionime Corporation, I-Sens, Inc. and Promisemed Hangzhou Meditech Co., Ltd..
List of Multiple Use Blood Lancet For Single Patient Use Only devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Multiple Use Blood Lancet For Single Patient Use Only devices (product code QRL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →