Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)— 510(k) K262631

Name: FDA 510(k) clearance K262631
Creator: U.S. Food and Drug Administration
Published: 2026-08-25

Substantially Equivalent

SteriLance 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.

Clearance details

Applicant: SteriLance Medical (Suzhou), Inc.
Product code: Code QRK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2026-07-29
Decision date: 2026-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRK

view all

K261634 — Disposable Blood Lancet (Soft)2026-06-12
K250016 — droplet® personal lancets2025-07-01
K244031 — Disposable Blood Lancet (4 models)2025-02-26
K242622 — Sterile Lancets for Single Use2024-10-28
K241810 — MICROLET®NEXT Lancet2024-08-15

More clearances from SteriLance Medical (Suzhou), Inc.

view all

K260122 — Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)2026-07-06
K244036 — Heel Incision Safety Lancet (SteriHeel 2)2025-02-26
K233796 — Disposable safety lancet (Impress) +4 more2024-01-16
K221521 — Disposable Safety Lancet2022-10-28
K221507 — Disposable Blood Lancet2022-08-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.