Cleared Special

safety lancet

K251694 · Tianjin Huahong Technology Co., Ltd. · General & Plastic Surgery

Jun 2025

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K251694 is an FDA 510(k) clearance for the safety lancet, 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 26, 2025, 24 days after receiving the submission on June 2, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K251694 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2025
Decision Date	June 26, 2025
Days to Decision	24 days
Submission Type	Special
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.