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510(k) K221419

TD-5010 Lancing Device and TD-5084 Sterile Lancets by Gostar Co., Ltd. — Product Code QRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2023
Date Received
May 16, 2022
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 Gostar Co., Ltd.

  • K241843 — TD-7301 Spirometer (TD-7301) (November 20, 2024)
  • K222810 — TD-7301 Peak Flow meter (December 19, 2023)

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  • K232912 — Facet Aurora Reusable Lancet Base (January 25, 2024)
  • K231797 — Medifun Lancing Device, Model No. LD-E1 (November 22, 2023)
  • K223643 — Verifine® Ease Lancing Device, Verifine® Lancing Device (February 21, 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)