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Lancing System, Sterile Lancet for Single Use, Lancing Device

by Shandong Lianfa Medical Plastic Products CO., LTD

510(k) K222472

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222472↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK222472 Date30 Nov 2022ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0226-2026 FDA Class III initiated 25 Jul 2025

    Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
QRL
FDA applicant
Shandong Lianfa Medical Plastic Products Co. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4850
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Multiple Use Blood Lancet for Single Patient Use Only, designed to create a controlled puncture in the skin for blood sampling or glucose monitoring. It consists of a sterile, disposable lancet and a lancing device that ensures precise depth control and minimal patient discomfort.

The system is intended for single-use in clinical or home settings, supplied sterile and packaged individually. It complies with FDA 510(k) clearance under regulation 878.4850 and is classified as a Class II medical device. Multiple reference codes (e.g., 3002680783, 1000525253) identify variations in gauge or design, all adhering to MDR and MDD standards.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is this lancing system designed for reuse across multiple patients, or is it intended for single-patient use only?

    This system is explicitly labeled as a *Multiple Use Blood Lancet for Single Patient Use Only*, meaning each lancet and device combination is intended for one patient only, even if the lancing device itself may be reused for subsequent single-patient procedures. The sterile, disposable lancet ensures safety and compliance with infection control standards.

  • How is the lancing system packaged, and what does the sterility guarantee entail?

    The system is supplied sterile and packaged individually, ensuring each lancet remains uncontaminated until use. The sterile packaging is critical for maintaining safety in both clinical and home settings, where blood sampling or glucose monitoring occurs.

  • What regulatory pathways has this device undergone, and how does that affect its use?

    The device has received FDA 510(k) clearance under regulation 878.4850, classifying it as a Class II medical device. It also complies with the EU’s Medical Device Directive (MDD) and Medical Device Regulation (MDR), ensuring it meets stringent safety and performance standards for use in regulated healthcare environments.

  • Are there different sizes or models available, and how would I identify them?

    Yes, multiple variations exist, identified by unique reference codes (e.g., 3002680783, 1000525253) that correspond to differences in gauge or design. These codes help distinguish models for specific clinical or patient needs, such as varying skin penetration depths or user preferences.