True Indicating Receives FDA Approval for CSPN-15 Type 5 Steam Integrator
TOLEDO, Ohio, May 12, 2025 /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.
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. 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.
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. 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.
"We are proud to receive FDA clearance for our CSPN-15, which represents years of dedicated research and development," said Bob Napierala, Co-Founder & CEO. "This approval reinforces our mission to support healthcare providers with products that meet the highest standards."
"Our CSPN-15 indicator is engineered for accuracy and reliability," said Thomas Riha, Chief Scientific Officer. "It offers confidence during every sterilization cycle—especially in high-stakes clinical environments."
Key Product Highlights:
- FDA-cleared Class II medical device (21 CFR 880.2800, Product Code: JOJ)
- Independent monitoring of steam sterilization parameters
- Visual endpoint: pink to dark brown/black, concealing "NOT"
- Validated per ISO 11140-1:2014 and FDA guidance
- 48-month shelf life with 6-month endpoint stability after exposure
About True Indicating, LLC: True Indicating is a privately held organization that was established in 2017. Based in Toledo, Ohio, 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.
Contact:
Rick Daschner
Director of Sales & Marketing
True Indicating, LLC
946 Kane St, Suite A
Toledo, Ohio 43612
(916) 755-2718
394858@email4pr.com
www.trueindicating.com
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SOURCE True Indicating