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DropSafe Acti-Lance Safety Lancets +3 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220643

by Htl Strefa S A

Identifiers

510(k) Number
K220643 FDA 510(k)
FDA Product Code
FMK FDA 510(k)
Models / Variants
DropSafe Acti-Lance Safety Lancets FDA 510(k)EUDAMED
droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets FDA 510(k)EUDAMED
droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets FDA 510(k)EUDAMED
DropSafe Haemolance Plus Safety Lancets FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4850 FDA 510(k)
Regulation Number
878.4850 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The DropSafe Acti-Lance Safety Lancets are single-use, disposable blood collection devices designed for safe and controlled skin puncture. These lancets incorporate a safety mechanism to prevent needle-stick injuries, ensuring user protection during blood sampling procedures. They are engineered for precision and ease of use in clinical and home healthcare settings, particularly for glucose monitoring and other capillary blood tests.

These lancets are supplied sterile and intended for single-use only, adhering to standard medical device safety and sterility protocols. They are classified under the product code FMK and comply with FDA 510(k) clearance, MDD, and MDR regulations. The devices are available in various models, including Acti-Lance, Medlance Plus, ergoLance, Prolance, Medisafe Solo, and Haemolance Plus, each tailored for specific puncture requirements. Storage should follow manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

Are these lancets reusable or designed for single-use only, and why does that matter for safety?

These lancets are explicitly designed for single-use only and are supplied sterile. The safety mechanism is engineered to prevent needle-stick injuries, which is critical for both user protection and infection control. Single-use ensures each puncture is performed with a sterile, uncontaminated device, reducing the risk of cross-infection and maintaining precision for accurate blood sampling.

What types of puncture tasks are these lancets intended for, and how do the different models differ?

These lancets are engineered for capillary blood collection, commonly used in glucose monitoring and other clinical or home healthcare blood tests. The models—Acti-Lance, Medlance Plus, ergoLance, Prolance, Medisafe Solo, and Haemolance Plus—are tailored to specific puncture requirements, such as depth control, ease of use, or ergonomic design. While all share the same safety mechanism, variations in blade geometry or grip may suit different patient needs or procedural preferences.

How should I store these lancets to ensure they remain sterile and functional until use?

Storage should follow the manufacturer’s guidelines to preserve sterility and functionality. Since they are sterile upon packaging, they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid opening the packaging until immediate use to prevent contamination. Proper storage ensures the lancets remain safe and effective for their intended single-use application.

Are these lancets regulated under specific standards, and what does that mean for compliance?

Yes, these lancets comply with FDA 510(k) clearance (K220643), as well as MDD (Medical Device Directive) and MDR (Medical Device Regulation) standards. This means they meet regulatory requirements for safety, performance, and manufacturing quality. For buyers or clinicians, this ensures the devices have undergone evaluation for their intended use—safe, single-use blood collection—and adhere to strict production and labeling standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Htl Strefa S A
FDA Applicant
Htl-Strefa S.A

Sources (2)

  • FDA 510(k) K220643 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026