Disposable Blood Lancets— 510(k) K223314

Name: FDA 510(k) clearance K223314
Creator: U.S. Food and Drug Administration
Published: 2023-01-25

Substantially Equivalent

Huaian Hening Medical Instruments Co., Ltd.

FDA 510(k) clearance K223314 for Disposable Blood Lancets, Substantially Equivalent on 2023-01-25. Applicant: Huaian Hening Medical Instruments Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huaian Hening Medical Instruments Co., Ltd.
Product code: Code QRK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2022-10-28
Decision date: 2023-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huaian, CN

Download summary PDF View on FDA.gov ↗

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K262631 — Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)2026-08-25
K261634 — Disposable Blood Lancet (Soft)2026-06-12
K250016 — droplet® personal lancets2025-07-01
K244031 — Disposable Blood Lancet (4 models)2025-02-26
K242622 — Sterile Lancets for Single Use2024-10-28

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K223313 — Disposable Safety Lancets2023-01-23

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