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FDA PRODUCT CODE · CLASS II

QRK — Single Use Only Blood Lancet Without 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, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

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
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K261634SteriLance Medical (Suzhou), Inc. · 510k2026-06-12
K250016Htl-Strefa S.A · 510k2025-07-01
K244031SteriLance Medical (Suzhou), Inc. · 510k2025-02-26
K242622Ningbo Caremed Medical Products Co., Ltd. · 510k2024-10-28

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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