Cleared Traditional

MICROLET?NEXT 2 Lancing Device

K250813 · Ascensia Diabetes Care U.S., Inc. · General & Plastic Surgery

May 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K250813 is an FDA 510(k) clearance for the MICROLET?NEXT 2 Lancing Device, a Multiple Use Blood Lancet For Single Patient Use Only (Class II — Special Controls, product code QRL), submitted by Ascensia Diabetes Care U.S., Inc. (Parsippany, US). The FDA issued a Cleared decision on May 14, 2025, 58 days after receiving the submission on March 17, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K250813 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2025
Decision Date	May 14, 2025
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	QRL — Multiple Use Blood Lancet For Single Patient Use Only
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4850
Definition	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.