Cleared Traditional

Safety Lancet (XXXV)

K241627 · Tianjin Huahong Technology Co., Ltd. · General & Plastic Surgery

Jun 2024

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K241627 is an FDA 510(k) clearance for the Safety Lancet (XXXV), a Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code FMK), submitted by Tianjin Huahong Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on June 20, 2024, 14 days after receiving the submission on June 6, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K241627 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2024
Decision Date	June 20, 2024
Days to Decision	14 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	FMK — Single Use Only Blood Lancet With 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, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use.