Home / 510(k) Clearances / K230310

510(k) K230310

STAT Medical Device Lancing System by Stat Medical Devices — Product Code QRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2023
Date Received
February 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device Class
Class II
Regulation Number
878.4850
Review Panel
SU
Submission Type

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Other clearances by Stat Medical Devices

  • K222617 — EasyTouch Lancing Device (March 21, 2023)
  • K223815 — ONE DROP Lancing Device (February 15, 2023)
  • K092016 — SUPER-FINE PEN NEEDLE (October 2, 2009)

Other clearances for product code QRK

  • K250016 — droplet® personal lancets (July 1, 2025)
  • K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposab (February 26, 2025)
  • K242622 — Sterile Lancets for Single Use (October 28, 2024)
  • K241810 — MICROLET®NEXT Lancet (August 15, 2024)
  • K232330 — Lancing System (January 4, 2024)
  • K230712 — SG Lanset I, SG Lancets, Soft Lancets (December 6, 2023)
  • K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro (June 13, 2023)
  • K222617 — EasyTouch Lancing Device (March 21, 2023)
  • K223815 — ONE DROP Lancing Device (February 15, 2023)
  • K223314 — Disposable Blood Lancets (January 25, 2023)