QRL

Multiple Use Blood Lancet For Single Patient Use Only

Product code
QRL
Device name
Multiple Use Blood Lancet For Single Patient Use Only
Device class
Class 2
21 CFR
21 CFR 878.4850
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
27

FDA classification definition

A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (8)

Last three years. Most recent: 2026-08-18.

NumberDecision dateApplicantDevice nameSummary
K2621352026-08-18Tianjin Huahong Technology Co., Ltd.Lancing devicePDF
K2622112026-07-22Tianjin Huahong Technology Co., Ltd.LancetPDF
K2601222026-07-06SteriLance Medical (Suzhou), Inc.Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStPDF
K2537062025-12-09Tianjin Huahong Technology Co., Ltd.Lancing device (HH-XV-T)PDF
K2508132025-05-14Ascensia Diabetes Care U.S., Inc.MICROLET®NEXT 2 Lancing DevicePDF
K2433062024-11-15Tianjin Huahong Technology Co., Ltd.Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, IIPDF
K2329122024-01-25Facet Technologies, LLCFacet Aurora Reusable Lancet BasePDF
K2317972023-11-22Medifun CorporationMedifun Lancing Device, Model No. LD-E1PDF

8 summaries are archived here for direct download.

Official FDA classification page: QRL
Classification and pathway per current FDA publications. Data from openFDA (CC0).