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FDA PRODUCT CODE · CLASS II

FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4850
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
10
510(K)/PMA CLEARANCES
510k: 10
0
RECALL ENTRIES

Recent clearances

K261045Promisemed Hangzhou Meditech Co., Ltd. · 510k2026-05-01
K260191Tianjin Huahong Technology Co., Ltd. · 510k2026-03-31
K253605Ningbo Medsun Medical Co., Ltd. · 510k2026-02-20
K252490Tianjin Huahong Technology Co., Ltd. · 510k2026-02-12
K251694Tianjin Huahong Technology Co., Ltd. · 510k2025-06-26
K244036SteriLance Medical (Suzhou), Inc. · 510k2025-02-26
K243533Hlb Co., Ltd. Healthcare · 510k2025-01-13
K242680Privapath Diagnostics Ltd (Dba Letsgetchecked) · 510k2025-01-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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