FDA.reportPublic FDA data

510(k) K222472

Device
Lancing System, Sterile Lancet For Single Use, Lancing Device
Applicant
Shandong Lianfa Medical Plastic Products Co. Ltd.
510(k) number
K222472
Product code
QRL  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-30
Date received
2022-08-16
Regulation
878.4850
Classification name
Multiple Use Blood Lancet For Single Patient Use Only
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Charles Shen
Address
# 1 Shuangshan Sanjian Rd., Zhangqiu Jinan CN 250200 250200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QRL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.2025-12-09
K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.2025-05-14
K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd.2024-11-15
K232912Facet Aurora Reusable Lancet BaseFacet Technologies, LLC2024-01-25
K231797Medifun Lancing Device, Model No. LD-E1Medifun Corporation2023-11-22
K223643Verifine® Ease Lancing Device, Verifine® Lancing DevicePromisemed Hangzhou Meditech Co., Ltd.2023-02-21
K221419TD-5010 Lancing Device and TD-5084 Sterile LancetsGostar Co., Ltd.2023-01-20
K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC2022-11-28
K222656LDE4 Lancing DeviceI-Sens, Inc.2022-11-23
K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.2022-11-21
K222539Facet Blood LancetsFacet Technologies, LLC2022-11-18
K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health2022-10-18
K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceArkray, Inc.2022-10-17
K221613Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet LancetsOwen Mumford, Ltd.2022-10-03
K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation2022-09-26

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases