True Indicating Secures FDA Clearance for CSPN-15 Steam Sterilization Monitoring Device
核心洞察
True Indicating (搜索) has received FDA 510(k) clearance for its CSPN-15 (搜索) Type 5 Integrating Indicator, a critical device that monitors steam sterilization parameters in healthcare settings.
The CSPN-15 (搜索) indicator provides visual confirmation of sterilization by changing from pink to dark brown/black when proper conditions are met, offering healthcare facilities enhanced infection control capabilities.
Validated for specific temperature-time parameters and compatible with multiple sterilization cycle types, the device represents a significant advancement in sterilization monitoring technology for hospitals, dental offices, and surgical centers.
True Indicating (搜索), LLC announced today that it has received FDA 510(k) clearance for its CSPN-15 (搜索) Type 5 Integrating Indicator for Steam, a critical advancement in sterilization monitoring technology. The clearance confirms the product's substantial equivalence to legally marketed predicate devices and enables the Toledo, Ohio-based company to introduce this sterilization assurance product to healthcare facilities nationwide.
The CSPN-15 (搜索) indicator addresses a fundamental need in infection control protocols, particularly in high-stakes environments such as hospitals, dental practices, and surgical centers where instrument sterility directly impacts patient safety.
"We are proud to receive FDA clearance for our CSPN-15 (搜索), which represents years of dedicated research and development," said Bob Napierala, Co-Founder & CEO of True Indicating (搜索). "This approval reinforces our mission to support healthcare providers with products that meet the highest standards."
Advanced Monitoring Capabilities
The newly approved device is engineered to react to all critical sterilization parameters—time, temperature, and steam—within specific tolerances during sterilization cycles. Its distinctive visual indicator transitions from pink to dark brown/black, concealing the word "NOT" when proper sterilization conditions have been achieved, providing immediate confirmation of process efficacy.
Thomas Riha, Chief Scientific Officer at True Indicating (搜索), emphasized the product's reliability: "Our CSPN-15 (搜索) indicator is engineered for accuracy and reliability. It offers confidence during every sterilization cycle—especially in high-stakes clinical environments."
The CSPN-15 (搜索) has undergone rigorous validation for specific minimum parameters in a resistometer:
- 121°C for 16.5 minutes
- 132°C for 2.0 minutes
- 134°C for 1.4 minutes
- 135°C for 1.2 minutes
This comprehensive validation ensures the indicator's performance across various sterilization protocols commonly employed in healthcare settings.
Technical Specifications and Compliance
As an FDA-cleared Class II medical device (21 CFR 880.2800, Product Code: JOJ), the CSPN-15 (搜索) provides independent monitoring of steam sterilization parameters. The product has been validated according to ISO 11140-1:2014 standards and FDA guidance, offering healthcare facilities enhanced compliance with regulatory requirements.
The indicator features a 48-month shelf life with 6-month endpoint stability after exposure, providing facilities with reliable performance over an extended period. Importantly, the CSPN-15 (搜索) is compatible with both gravity displacement and dynamic air removal (vacuum assist) sterilization cycles, making it versatile across different sterilization equipment configurations.
Impact on Infection Control Practices
Sterilization process indicators play a vital role in comprehensive infection control programs. By providing visual confirmation that sterilization conditions have been met, the CSPN-15 (搜索) helps healthcare facilities reduce risk and improve compliance with increasingly stringent regulatory standards.
The FDA approval not only validates the product's safety and performance but also supports True Indicating (搜索)'s ongoing commitment to delivering precise, science-backed sterilization solutions to healthcare professionals.
About True Indicating
Founded in 2017, True Indicating (搜索) is a privately held organization based in Toledo, Ohio. The company specializes in providing high-quality sterilization and disinfection monitoring products and expert services to medical device manufacturers, healthcare facilities, dental practices, laboratories, industrial clients, and pharmaceutical, life science, and biotechnology companies.
With over 35 years of combined experience, True Indicating (搜索) emphasizes science-based service and partnerships with clients. The FDA clearance of the CSPN-15 (搜索) Type 5 Integrating Indicator represents a significant milestone in the company's mission to advance sterilization monitoring technologies.