510(k) K241810

MICROLET®NEXT Lancet by Ascensia Diabetes Care U.S., Inc. — Product Code QRK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 15, 2024
Date Received: June 21, 2024
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 Ascensia Diabetes Care U.S., Inc.

K250813 — MICROLET®NEXT 2 Lancing Device (May 14, 2025)
K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc (August 27, 2024)
K223293 — CONTOUR® NEXT GEN Blood Glucose Monitoring System (November 18, 2022)
K220633 — MICROLET NEXT lancing device, MICROLET Lancet (June 3, 2022)
K162336 — Contour Next EZ Blood Glucose Monitoring System (January 12, 2017)
K160430 — Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood G (June 24, 2016)

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)
K232330 — Lancing System (January 4, 2024)
K230712 — SG Lanset I, SG Lancets, Soft Lancets (December 6, 2023)
K230310 — STAT Medical Device Lancing System (September 8, 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)