Cleared Traditional

DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets

K220643 · Htl-Strefa S.A · General & Plastic Surgery

Jul 2022

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K220643 is an FDA 510(k) clearance for the DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets, a Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code FMK), submitted by Htl-Strefa S.A (Ozorkow, PL). The FDA issued a Cleared decision on July 8, 2022, 126 days after receiving the submission on March 4, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K220643 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2022
Decision Date	July 08, 2022
Days to Decision	126 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.