FDA 510(k)

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

Número K: K262631 · 2026-08-25

RequerenteSteriLance Medical (Suzhou), Inc.

Data da decisão2026-08-25

Código do produtoQRK

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) is the device name listed in this FDA 510(k) record. The listed applicant is SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2026-08-25 under 510(k) number K262631. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)?

Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K262631.

When did Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) receive FDA 510(k) clearance?

Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) received FDA 510(k) clearance on 2026-08-25, under 510(k) number K262631.

Who is the listed applicant for Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)?

The FDA 510(k) record lists SteriLance Medical (Suzhou), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)?

The FDA product code for Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) is QRK.

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Outros registros que listam SteriLance Medical (Suzhou), Inc. como candidato(a)

K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)K261634Disposable Blood Lancet (Soft)K244036Heel Incision Safety Lancet (SteriHeel 2)K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)K221521Disposable Safety Lancet

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: QRK)

K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.K250016droplet® personal lancetsHtl-Strefa S.A K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)SteriLance Medical (Suzhou), Inc.K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.K232330Lancing SystemNingbo Medsun Medical Co., Ltd.

Fonte oficial

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