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510(k) K231797

Medifun Lancing Device, Model No. LD-E1 by Medifun Corporation — Product Code QRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2023
Date Received
June 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Use Blood Lancet For Single Patient Use Only
Device Class
Class II
Regulation Number
878.4850
Review Panel
SU
Submission Type

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.

Other clearances by Medifun Corporation

  • K241750 — Medifun Safety Lancet ( MSL1 series) (August 15, 2024)

Other clearances for product code QRL

  • K253706 — Lancing device (HH-XV-T) (December 9, 2025)
  • K250813 — MICROLET®NEXT 2 Lancing Device (May 14, 2025)
  • K243306 — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); La (November 15, 2024)
  • K232912 — Facet Aurora Reusable Lancet Base (January 25, 2024)
  • K223643 — Verifine® Ease Lancing Device, Verifine® Lancing Device (February 21, 2023)
  • K221419 — TD-5010 Lancing Device and TD-5084 Sterile Lancets (January 20, 2023)
  • K222472 — Lancing System, Sterile Lancet for Single Use, Lancing Device (November 30, 2022)
  • K223099 — Facet Manatee Reusable Lancing Base (November 28, 2022)
  • K222656 — LDE4 Lancing Device (November 23, 2022)
  • K222246 — Disposable Sterile Lancet (November 21, 2022)