FDA 510(k)

droplet®个人采血针

K号: K250016 · 2025-07-01

决定日期2025-07-01

产品代码QRK

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决定实质等同

器械摘要

droplet® personal lancets is the device name listed in this FDA 510(k) record. The listed applicant is Htl-Strefa S.A. It received FDA 510(k) clearance on 2025-07-01 under 510(k) number K250016. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the droplet® personal lancets?

droplet® personal lancets is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Htl-Strefa S.A. The 510(k) number is K250016.

When did droplet® personal lancets receive FDA 510(k) clearance?

droplet® personal lancets received FDA 510(k) clearance on 2025-07-01, under 510(k) number K250016.

Who is the listed applicant for droplet® personal lancets?

The FDA 510(k) record lists Htl-Strefa S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for droplet® personal lancets?

The FDA product code for droplet® personal lancets is QRK.

列明Htl-Strefa S.A为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K220643DropSafe Acti-Lance 安全注射针；滴液 ACTI-LANCE 安全注射针，DropSafe Medlance Plus 安全注射针；滴液 MEDLANCE PLUS 安全注射针，DropSafe ergoLance 安全注射针，DropSafe Prolance 安全注射针，DropSafe Medisafe Solo 安全注射针；DropSafe Haemolance Plus 安全注射针 K202340Droplet Pen Needle 30G & 33G K192082Droplet Pen Needle 34G K171982DROPLET 笔式注射针 K170988DropSafe 安全笔式注射针

相关器械（代码：QRK）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262631一次性血刺针（Soft Pro，Softsure，Softsure Pro，Softsense）SteriLance Medical (Suzhou), Inc.K261634一次性血刺针（软）SteriLance Medical (Suzhou), Inc.K244031一次性血刺针（软Pro）；一次性血刺针（Softsure）；一次性血刺针（Softsure Pro）；一次性血刺针（Softsense）SteriLance Medical (Suzhou), Inc.K242622一次性无菌 lancetsNingbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT 刺针Ascensia Diabetes Care U.S., Inc.K232330刺针系统Ningbo Medsun Medical Co., Ltd.

官方来源

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