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FDA 510(k)

Disposable Blood Lancet (Soft)

K-Number: K261634 · 2026-06-12

ApplicantSteriLance Medical (Suzhou), Inc.
Decision Date2026-06-12
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Blood Lancet (Soft) 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 2026-06-12 under 510(k) number K261634. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Blood Lancet (Soft)?

Disposable Blood Lancet (Soft) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K261634.

When did Disposable Blood Lancet (Soft) receive FDA 510(k) clearance?

Disposable Blood Lancet (Soft) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261634.

Who is the listed applicant for Disposable Blood Lancet (Soft)?

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)?

The FDA product code for Disposable Blood Lancet (Soft) is QRK.

Other records listing SteriLance Medical (Suzhou), Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)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 LancetK221507Disposable Blood Lancet

View all 10 devices →

Related Devices (Code: QRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250016droplet® personal lancetsHtl-Strefa S.AK244031Disposable 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.K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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