510(k) K262631
K262631 is an FDA 510(k) premarket notification submitted by SteriLance Medical (Suzhou), Inc. for the device "Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)". The FDA issued a decision of Substantially Equivalent on August 25, 2026. The device falls under product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850. SteriLance Medical (Suzhou), Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2026
- Date Received
- July 29, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- Device Class
- Class II
- Regulation Number
- 878.4850
- Review Panel
- SU
- Submission Type
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.