Cleared Traditional

Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)

K244031 · SteriLance Medical (Suzhou), Inc. · General & Plastic Surgery

Feb 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K244031 is an FDA 510(k) clearance for the Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense), 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 February 26, 2025, 58 days after receiving the submission on December 30, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K244031 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2024
Decision Date	February 26, 2025
Days to Decision	58 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.