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FDA 510(k)

Hudson RCI® 婴儿Dri-TechTM 呼吸回路（HUD99060 / Dri-Tech 婴儿回路，HUD99060KIT / Dri-Tech 婴儿回路套件，HUD99001KIT / 单肢婴儿回路Dri-Tech 套件，HUD99009KIT / Dri-Tech 婴儿回路套件，HUD99018KIT / Dri-Tech 婴儿回路套件，HUD870NKIT / Dri-Tech 婴儿附件袋，HUD1631 / 婴儿Y型连接器带旋转接头）

K号: K253322 · 2026-03-25

申请人Medline Industries, LP
决定日期2026-03-25
产品代码BZE
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K253322. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)?

Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Medline Industries, LP. The 510(k) number is K253322.

When did Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) receive FDA 510(k) clearance?

Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) received FDA 510(k) clearance on 2026-03-25, under 510(k) number K253322.

Who is the listed applicant for Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)?

FDA 510(k)记录显示Medline Industries, LP为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)?

The FDA product code for Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) is BZE.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Medline Industries, LP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。

K253526NAMIC 扩张器和套管K254287Medline 可重复使用血压袖带K251687Konig 贝尔环状包皮环切夹K253070Namic径向臂带，23厘米（DYNJRADBAND）；Namic径向臂带，26厘米（DYNJRADBANDL）K250345Medline 袋式过滤器K250312Hudson RCI® Comfort Flo 鼻导管早产儿，婴儿；Hudson RCI® Comfort Flo Plus 和 Soft Plus 鼻导管超小号

查看所有 31 个设备 →

相关器械（代码：BZE）

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。

K252066inspired™ 加热呼吸回路（510-008）；inspired™ 加热呼吸回路（510-009）；inspired™ 自动进料加湿室（VHC10）；inspired™ 自动进料加湿室（VHC20）Vincent Healthcare Products LimitedK243244加热呼吸管Guangdong Eda Technology Co., Ltd.K241268Thermalite 加热 CPAP 管道（CTUBH06H15DS-2, CTUBH15-DS）Exceleron MedicalK234032Hudson RCI Dri-Tech 呼吸回路；HUD99035/Dri-Tech 成人回路；HUD99035KIT/Dri-Tech 成人回路套件；HUD99098KIT/单肢成人Dri-Tech 套件；HUD99098KITF/单肢成人Dri-Tech 过滤器套件；HUD900/Dri-Tech 呼吸机附件；HUD901/Dri-Tech 呼吸机附件延长线Medline Industries, LPK222822VentStar Helix 双加热（N）Plus（MP02650），VentStar Helix 加热（N）Plus（MP02608）Draegerwerk AG & CO KgaaK201418Sunset加热CPAP管Sunset Healthcare Solutions, Inc.

官方来源

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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。

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