Cleared Traditional

Disposable Blood Lancet

K221507 · SteriLance Medical (Suzhou), Inc. · General & Plastic Surgery

Aug 2022

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K221507 is an FDA 510(k) clearance for the Disposable Blood Lancet, a Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code QRK), submitted by SteriLance Medical (Suzhou), Inc. (Suzhou, CN). The FDA issued a Cleared decision on August 31, 2022, 100 days after receiving the submission on May 23, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K221507 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2022
Decision Date	August 31, 2022
Days to Decision	100 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.