Cleared Traditional

Facet 28G Universal Lancet

K221433 · Facet Technologies, LLC · General & Plastic Surgery

Jul 2022

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K221433 is an FDA 510(k) clearance for the Facet 28G Universal Lancet, a Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code QRK), submitted by Facet Technologies, LLC (Atlanta, US). The FDA issued a Cleared decision on July 15, 2022, 59 days after receiving the submission on May 17, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K221433 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 17, 2022
Decision Date	July 15, 2022
Days to Decision	59 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.