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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 the device name listed in this FDA 510(k) record. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. It received FDA 510(k) clearance on 2022-11-30 under 510(k) 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. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. The 510(k) number is K222472.

When did Lancing System, Sterile Lancet for Single Use, Lancing Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Lancing System, Sterile Lancet for Single Use, Lancing Device?

The FDA 510(k) record lists Shandong Lianfa Medical Plastic Products Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shandong Lianfa Medical Plastic Products Co. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: QRL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262211LancetTianjin Huahong Technology Co., Ltd.K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.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.K232912Facet Aurora Reusable Lancet BaseFacet Technologies, LLC

Official Source

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

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