True Indicating Receives FDA Approval for CSPN-15 Type 5 Steam Integrator
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TOLEDO, Ohio, May 12, 2025 ~ True Indicating, LLC, a leading company in sterilization monitoring technologies, has recently announced that their CSPN-15 Type 5 Integrating Indicator for Steam has received FDA 510(k) clearance. This clearance serves as confirmation of the product's substantial equivalence to other legally marketed devices and allows True Indicating to bring this crucial sterilization assurance product to the market.

Sterilization process indicators are essential in infection control, especially in settings such as hospitals, dental offices, and surgical centers where instrument sterility is of utmost importance. The CSPN-15 Type 5 Integrating Indicator is specifically designed to react to critical parameters like time, temperature, and steam within specific tolerances during the sterilization cycle. Its visual signal changes from pink to dark brown/black and conceals the word "NOT," providing immediate confirmation that sterilization conditions have been met.

The CSPN-15 has been validated for specific minimum 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, making it suitable for reducing risk and improving compliance with regulatory standards. The FDA approval not only validates the product's safety and performance but also supports True Indicating's commitment to delivering precise and scientifically-backed sterilization solutions to healthcare professionals.

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Bob Napierala, Co-Founder & CEO of True Indicating expressed his pride in receiving FDA clearance for their CSPN-15 after years of dedicated research and development. He stated that this approval reinforces their mission to provide healthcare providers with products that meet the highest standards.

Chief Scientific Officer Thomas Riha also highlighted some key features of the CSPN-15 indicator, stating that it is engineered for accuracy and reliability. He added that it offers confidence during every sterilization cycle, especially in high-stakes clinical environments.

Some key highlights of the CSPN-15 indicator include its FDA-cleared Class II medical device status, independent monitoring of steam sterilization parameters, visual endpoint from pink to dark brown/black, validation per ISO 11140-1:2014 and FDA guidance, and a 48-month shelf life with 6-month endpoint stability after exposure.

With this FDA clearance, True Indicating is set to make a significant impact in the field of sterilization monitoring and provide healthcare professionals with a reliable and accurate solution for ensuring instrument sterility.

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