FDA 510(k)

ADRx® 混合设备

K号: K252987 · 2026-06-12

决定日期2026-06-12

产品代码LHI

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

ADRx™ Admixture Device is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252987. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADRx™ Admixture Device?

ADRx™ Admixture Device is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K252987.

When did ADRx™ Admixture Device receive FDA 510(k) clearance?

ADRx™ Admixture Device received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252987.

Who is the listed applicant for ADRx™ Admixture Device?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADRx™ Admixture Device?

The FDA product code for ADRx™ Admixture Device is LHI.

列明Epic Medical Pte. , Ltd.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。

K250234SMARTeZ® 弹性输液泵（RS 系列）K251722ProSeal™ 转移注射器 (421120, 421130, 421140)K251814EZ® 静脉注射给药装置 K252094eZSURE™ 空液容器 K251340ProSeal™带添加剂端口的袋刺（423370ST，423370）K243976ZeroClear™袋接入（423100）

查看所有 22 个设备 →

相关器械（代码：LHI）

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。

K260301药瓶适配器Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline 袋式过滤器Medline Industries, LP K251715FlowArt® 安瓿瓶接入通风装置Asset Medikal K251676Medline Microtek C-Flo 瓶式过滤器，无菌（2000S）；Medline Microtek 瓶式过滤器 II，无菌（2002S）；Medline Microtek 瓶式过滤器，无菌（2006S）；Medline Microtek 转移装置，无菌（2008S）Microtek Medical, LLC K243404HyHub™ 和 HyHub™ Duo 瓶盖访问设备Takeda Pharmaceuticals K240761Arisure® 闭式雄性鲁尔带刺适配器 (YM060)Yukon Medical, LLC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。