Cleared Traditional

DropSafe Acti-Lance Safety Lancets (K220643) - FDA 510(k) Clearance

Also marketed or referenced as:
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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220643 · Htl-Strefa S.A · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
126d
Days
Class 2
Risk

K220643 is an FDA 510(k) clearance for the DropSafe Acti-Lance Safety Lancets. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Htl-Strefa S.A (Ozorkow, PL). The FDA issued a Cleared decision on July 8, 2022 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4850 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Htl-Strefa S.A devices

Submission Details

510(k) Number K220643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

All 63
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K220643.
SafetiHeel, MediHeel, Novaplus
K221604 · Nsp Tech Pte, Ltd. · Aug 2022
Unistik® 3, sterile single-use safety lancets
K221126 · Owen Mumford, Ltd. · Aug 2022
Tasso+
K221131 · Tasso, Inc. · Aug 2022
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K221368 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2022
Promisemed Heel Blood Lancet
K221371 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220370 · Tianjin Huahong Technology Co., Ltd. · May 2022