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FDA 510(k)

Medifun Lancing Device, Model No. LD-E1

K-Number: K231797 · 2023-11-22

ApplicantMedifun Corporation
Decision Date2023-11-22
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medifun Lancing Device, Model No. LD-E1 is a medical device manufactured by Medifun Corporation. It received FDA 510(k) clearance on 2023-11-22 under approval number K231797. 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 Medifun Lancing Device, Model No. LD-E1?

Medifun Lancing Device, Model No. LD-E1 is a medical device that received FDA 510(k) clearance on 2023-11-22. It is manufactured by Medifun Corporation. The 510(k) number is K231797.

When was Medifun Lancing Device, Model No. LD-E1 approved by the FDA?

Medifun Lancing Device, Model No. LD-E1 received FDA 510(k) clearance on 2023-11-22, under approval number K231797.

What company makes Medifun Lancing Device, Model No. LD-E1?

Medifun Lancing Device, Model No. LD-E1 is manufactured by Medifun Corporation.

What is the FDA product code for Medifun Lancing Device, Model No. LD-E1?

The FDA product code for Medifun Lancing Device, Model No. LD-E1 is QRL.

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Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023) PMID: 36103178 Estimated Cost of Developing a Therapeutic Complex Medical Device in the US. JAMA network open (2022)

Other Devices by Medifun Corporation

K241750Medifun Safety Lancet ( MSL1 series)

Related Devices (Code: QRL)

K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. 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

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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