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FDA 510(k)

Celerity 5 HP 生物指示剂（LCB052）；Celerity 5 HP 挑战包（LCB059）；Celerity 20 HP 生物指示剂（LCB044）；Celerity 20 HP 挑战包（LCB045）

K号: K250044 · 2025-02-06

申请人STERIS Corporation
决定日期2025-02-06
产品代码FRC
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

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K250044. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)?

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is STERIS Corporation. The 510(k) number is K250044.

When did Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) receive FDA 510(k) clearance?

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) received FDA 510(k) clearance on 2025-02-06, under 510(k) number K250044.

Who is the listed applicant for Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)?

The FDA product code for Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) is FRC.

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STERIS Corporation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。

K261055AMSCO 700 蒸汽灭菌器K260766Celerity 5 HP 生物指示剂（LCB052）K251666SYSTEM 1E 液体化学灭菌剂处理系统，型号 P6700；SYSTEM 1 内窥镜液体化学灭菌剂处理系统，型号 P6900K252680Celerity™ 20 HP 生物指示剂K251048Rapicide PA 高级消毒测试条 模型参考号 = ML02-0118K243876验证蒸汽集成指示器

查看所有 120 个设备 →

相关器械（代码：FRC）

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。

K260766Celerity 5 HP 生物指示剂（LCB052）STERIS CorporationK252680Celerity™ 20 HP 生物指示剂STERIS CorporationK251122Terragene® Bionova® BT20 生物指示器TerrageneK251452Celerity 5 HP 生物指示剂（LCB052）；Celerity 5 HP 挑战包（LCB059）；Celerity 20 HP 生物指示剂（LCB044）；Celerity 20 HP 挑战包（LCB045）SterisK250061Celerity 孵化箱STERIS CorporationK2435013M™ Attest™ 超快速蒸汽延长周期清晰挑战包 1492PCDE；3M™ Attest™ 自动读取器 490；3M™ Attest™ 自动读取器 490H；3M™ Attest™ 迷你自动读取器 490M3M Company

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。

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