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Safety Heel Lancet

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253605

by Ningbo Medsun Medical Co., Ltd.

Identifiers

510(k) Number
K253605 FDA 510(k)
FDA Product Code
FMK FDA 510(k)

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 Safety Heel Lancet is a single-use, disposable medical device classified as a surgical lancet under the FDA’s product code FMK. Designed for controlled skin penetration, it is intended for procedures requiring precise, shallow punctures, such as heel stick blood sampling in clinical settings. Constructed from plastic, it ensures minimal trauma while maintaining sterility and safety for patient use.

Supplied sterile in a sealed, individually packaged form, the lancet is intended for single-use only to prevent cross-contamination. It is regulated under the FDA’s 510(k) pathway, with clearance granted as substantially equivalent to predicate devices. Compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) ensures adherence to stringent European safety standards. No MRI safety information is provided, and storage requires protection from moisture and physical damage.

Frequently asked questions

What types of procedures is the Safety Heel Lancet specifically designed for, and why is it preferred in clinical settings?

The Safety Heel Lancet is designed for controlled skin penetration, particularly for heel stick blood sampling in clinical settings. It is preferred because its shallow, precise puncture minimizes patient trauma while ensuring safe and sterile access to blood. The single-use, disposable design also prevents cross-contamination, making it ideal for repeated or high-volume procedures where sterility and consistency are critical.

How is the Safety Heel Lancet packaged and stored, and what precautions should be taken during handling?

The Safety Heel Lancet is supplied sterile in a sealed, individually packaged form to maintain sterility until use. It is intended for single-use only, so each package should remain unopened until immediately before use. Storage requires protection from moisture and physical damage to preserve its integrity. Avoid exposing the packaging to extreme temperatures or direct sunlight, as this could compromise the device’s sterility or structural integrity.

Is the Safety Heel Lancet reusable, and if not, what are the implications for clinical workflows?

No, the Safety Heel Lancet is explicitly designed for single-use only to prevent cross-contamination and ensure patient safety. Clinically, this means each lancet must be discarded after one use, requiring proper disposal protocols and restocking procedures. While this may increase waste management considerations, it aligns with best practices for infection control and sterility in medical settings.

What regulatory pathways does the Safety Heel Lancet follow, and how does this affect its availability in different markets?

The Safety Heel Lancet is cleared under the FDA’s 510(k) pathway as substantially equivalent to predicate devices, ensuring compliance with U.S. safety standards. It also adheres to the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in Europe, enabling its distribution in markets requiring these certifications. This dual regulatory compliance allows for broader availability while maintaining adherence to stringent safety and quality requirements across regions.

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

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ningbo Medsun Medical Co., Ltd.

Sources (2)

  • FDA 510(k) K253605 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026