Cleared Traditional

MICROLET?NEXT Lancet

K241810 · Ascensia Diabetes Care U.S., Inc. · General & Plastic Surgery

Aug 2024

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K241810 is an FDA 510(k) clearance for the MICROLET?NEXT Lancet, a Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code QRK), submitted by Ascensia Diabetes Care U.S., Inc. (Parsippany, US). The FDA issued a Cleared decision on August 15, 2024, 55 days after receiving the submission on June 21, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K241810 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2024
Decision Date	August 15, 2024
Days to Decision	55 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	QRK — Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4850
Definition	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.