Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)— 510(k) K222376

Name: FDA 510(k) clearance K222376
Creator: U.S. Food and Drug Administration
Published: 2022-10-03

Substantially Equivalent

Shandong Lianfa Medical Plastic Products Co. , Ltd.

FDA 510(k) clearance K222376 for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA), Substantially Equivalent on 2022-10-03. Applicant: Shandong Lianfa Medical Plastic Products Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Shandong Lianfa Medical Plastic Products Co. , Ltd.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2022-08-05
Decision date: 2022-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jinan, CN

Download summary PDF View on FDA.gov ↗

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K253605 — Safety Heel Lancet2026-02-20
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K222472 — Lancing System, Sterile Lancet for Single Use, Lancing Device2022-11-30

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.