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The Tracker / August 2026 / K262631

510(k) cleared

Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)

SteriLance Medical (Suzhou), Inc. · Aug 25, 2026 · K262631

FDA cleared the Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) from SteriLance Medical (Suzhou), Inc. on Aug 25, 2026 under K262631, a special 510(k). The device falls under product code QRK, Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, regulated at 21 CFR 878.4850 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 29, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

SteriLance Medical (Suzhou), Inc. has 2 other decisions in the tracker over the last 12 months: K260122 (Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)), K261634 (Disposable Blood Lancet (Soft)).

Questions & Answers

What did FDA clear under K262631?

K262631 is the FDA 510(k) for Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense), submitted by SteriLance Medical (Suzhou), Inc.. FDA's decision date was Aug 25, 2026, under product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature).

Who makes the Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)?

SteriLance Medical (Suzhou), Inc., based in Suzhou, is the applicant of record for K262631.

How long did the K262631 review take?

FDA received the submission on Jul 29, 2026 and issued its decision on Aug 25, 2026, 27 days later.

← All decisions in August 2026

Sources