Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)— 510(k) K262631
Substantially EquivalentSteriLance Medical (Suzhou), Inc.
FDA 510(k) clearance K262631 for Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense), Substantially Equivalent on 2026-08-25. Applicant: SteriLance Medical (Suzhou), Inc.. Device class: 2.
Summary
SteriLance Medical (Suzhou) filed a Disposable blood lancet in four listed versions: Soft Pro, Softsure, Softsure Pro, and Softsense. Product code QRK covers single use only blood lancets without an integral sharps injury prevention feature.
Class II, 21 CFR 878.4850. General and Plastic Surgery is both the classification panel and the review panel, and the submission type is Special.
SteriLance filed from Suzhou, China. Review took 27 calendar days (July 29 to August 25, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- SteriLance Medical (Suzhou), Inc.
- Product code
- Product code QRK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Suzhou, CN
Recent devices under product code QRK
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