Cleared Traditional

MICROLET NEXT lancing device, MICROLET Lancet

K220633 · Ascensia Diabetes Care U.S., Inc. · General & Plastic Surgery

Jun 2022

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K220633 is an FDA 510(k) clearance for the MICROLET NEXT lancing device, MICROLET Lancet, 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 June 3, 2022, 91 days after receiving the submission on March 4, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K220633 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2022
Decision Date	June 03, 2022
Days to Decision	91 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.