/PRNewswire/ --True Indicating, LLC, a leader in sterilization monitoring technologies, announces FDA 510(k) clearance for its CSPN-15 Type 5 Integrating Indicator for Steam. This clearance confirms the product's substantial equivalence to legally marketed predicate devices and allows the company to bring this critical sterilization assurance product to market..

/PRNewswire/ -- 灭菌监测技术领域的领导者True Indicating, LLC宣布，其CSPN-15型5蒸汽整合指示剂获得了FDA 510(k)许可。该许可确认了该产品与合法上市的对照设备具有实质等效性，并允许公司将这一关键的灭菌保障产品推向市场。

Sterilization process indicators play a vital role in infection control, particularly in hospitals, dental offices, and surgical centers where instrument sterility is critical. The CSPN-15 Type 5 Integrating Indicator is designed to react to all critical parameters such as time, temperature, and steam within specific tolerances during the sterilization cycle.

灭菌过程指示器在感染控制中起着至关重要的作用，尤其是在医院、牙科诊所和手术中心等对器械无菌性要求极高的场所。CSPN-15型5综合指示器旨在对灭菌周期内的所有关键参数（如时间、温度和蒸汽）在特定容差范围内作出反应。

It's clear visual signal, transitioning from pink to dark brown/black to conceal the word 'NOT,' provides immediate confirmation that sterilization conditions have been met..

这是一个清晰的视觉信号，从粉红色过渡到深棕色/黑色以隐藏“NOT”这个词，提供了立即确认灭菌条件已满足的依据。

The CSPN-15 has been validated for specific minimum stated values in a resistometer: 121°C for 16.5 minutes, 132°C for 2.0 minutes, 134°C for 1.4 minutes, and 135°C for 1.2 minutes. It is compatible with both gravity displacement and dynamic air removal (vacuum assist) cycles, helping reduce risk and improve compliance with regulatory standards.

CSPN-15 已在电阻仪中验证了特定的最低标称值：121°C 下 16.5 分钟、132°C 下 2.0 分钟、134°C 下 1.4 分钟以及 135°C 下 1.2 分钟。它兼容重力置换和动态空气移除（真空辅助）循环，有助于降低风险并提高对法规标准的合规性。

The FDA approval not only validates the product's safety and performance but also supports True Indicating's ongoing commitment to delivering precise, science-backed sterilization solutions to healthcare professionals..

FDA的批准不仅验证了产品的安全性和性能，还支持了True Indicating持续致力于为医疗专业人员提供精确、基于科学的灭菌解决方案。

'We are proud to receive FDA clearance for our CSPN-15, which represents years of dedicated research and development,' said

“我们为CSPN-15获得FDA批准感到自豪，这代表了多年专注的研究和开发，”

Bob Napierala

鲍勃·纳皮拉拉

, Co-Founder & CEO. 'This approval reinforces our mission to support healthcare providers with products that meet the highest standards.'

，联合创始人兼首席执行官。“这一批准进一步巩固了我们为医疗保健提供者提供符合最高标准的产品的使命。”

'Our CSPN-15 indicator is engineered for accuracy and reliability,' said

“我们的CSPN-15指标设计精确且可靠，”

Thomas Riha

托马斯·里哈

, Chief Scientific Officer. 'It offers confidence during every sterilization cycle—especially in high-stakes clinical environments.'

，首席科学官。“它在每次灭菌周期中都提供了信心，特别是在高风险的临床环境中。”

Key Product Highlights:

产品主要亮点：

FDA-cleared Class II medical device (21 CFR 880.2800, Product Code: JOJ)

FDA认证的II类医疗器械（21 CFR 880.2800，产品代码：JOJ）

Independent monitoring of steam sterilization parameters

独立监控蒸汽灭菌参数

Visual endpoint: pink to dark brown/black, concealing 'NOT'

视觉终点：粉红色到深棕色/黑色，遮盖“NOT”

Validated per ISO 11140-1:2014 and FDA guidance

根据ISO 11140-1:2014和FDA指南验证

48-month shelf life with 6-month endpoint stability after exposure

48个月的保质期，暴露后6个月的终点稳定性

About True Indicating, LLC: True Indicating is a privately held organization that was established in 2017. Based in

关于True Indicating有限责任公司：True Indicating是一家私营组织，成立于2017年。总部位于

Toledo, Ohio

俄亥俄州托莱多市

, we have been committed to providing the highest-quality sterilization and disinfection monitoring products and expert services to medical device manufacturers, healthcare, dental, lab services, industrial, pharmaceutical, life science, and biotechnology companies. With over 35 years of combined experience, our focus is science-based service, allowing us to identify True solutions and True partnerships with our clients..

，我们一直致力于为医疗设备制造商、医疗机构、牙科、实验室服务、工业、制药、生命科学和生物技术公司提供最高质量的灭菌和消毒监测产品以及专家服务。凭借超过35年的综合经验，我们的重点是基于科学的服务，使我们能够为客户找到真正的解决方案并建立真正的合作伙伴关系。