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FDA 510(k)

Lancing System, Sterile Lancet for Single Use, Lancing Device

K-Number: K222472 · 2022-11-30

ApplicantShandong Lianfa Medical Plastic Products Co. , Ltd.
Decision Date2022-11-30
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lancing System, Sterile Lancet for Single Use, Lancing Device is a medical device manufactured by Shandong Lianfa Medical Plastic Products Co. , Ltd.. It received FDA 510(k) clearance on 2022-11-30 under approval number K222472. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lancing System, Sterile Lancet for Single Use, Lancing Device?

Lancing System, Sterile Lancet for Single Use, Lancing Device is a medical device that received FDA 510(k) clearance on 2022-11-30. It is manufactured by Shandong Lianfa Medical Plastic Products Co. , Ltd.. The 510(k) number is K222472.

When was Lancing System, Sterile Lancet for Single Use, Lancing Device approved by the FDA?

Lancing System, Sterile Lancet for Single Use, Lancing Device received FDA 510(k) clearance on 2022-11-30, under approval number K222472.

What company makes Lancing System, Sterile Lancet for Single Use, Lancing Device?

Lancing System, Sterile Lancet for Single Use, Lancing Device is manufactured by Shandong Lianfa Medical Plastic Products Co. , Ltd..

What is the FDA product code for Lancing System, Sterile Lancet for Single Use, Lancing Device?

The FDA product code for Lancing System, Sterile Lancet for Single Use, Lancing Device is QRL.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026)

Other Devices by Shandong Lianfa Medical Plastic Products Co. , Ltd.

K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)

Related Devices (Code: QRL)

K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC K222656LDE4 Lancing DeviceI-Sens, Inc. K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceArkray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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