Cross-Checks

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K951113 ↗

FDA Product Code

LRT

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Steritec Green Card Pack Bowie-Dick Test

  Class II

  FDA 510(k) K132372 Active Cleared 26 Nov 2013

• Emu-Graph Emulator, Model Ci 131

  Class II

  FDA 510(k) K072408 Active Cleared 30 Apr 2008

• Steri-Pak Bowie Dick Test Pack

  Class II

  FDA 510(k) K982188 Active Cleared 20 Nov 1998

• Steritec Cross-Checks Eo Gas Sterilization Integrator

  Class II

  FDA 510(k) K982547 Active Cleared 8 Oct 1998

• Steritec Lead Free Sterilization Process Indicator Tape

  Class II

  FDA 510(k) K122555 Active Cleared 12 Dec 2012

• Steritec Integraph Model Ci-101

  Class II

  FDA 510(k) K960441 Active Cleared 8 May 1997

See all devices from Steritec Products Mfg. Co., Inc. →

• What is the Cross-Checks EO Integrator used for in an EO sterilization process?

  The Cross-Checks EO Integrator is a Type 4 Multicritical Process Variable Indicator specifically designed to monitor and visually confirm that Ethylene Oxide (EO) sterilization cycles meet the required temperature parameters—between 132°C and 135°C (270°F–276°F)—for medical devices and instruments. It ensures process integrity by providing a visual confirmation that the sterilization conditions were achieved, helping to validate the effectiveness of the cycle.

• How is the Cross-Checks device supplied, and is it reusable?

  The Cross-Checks device is supplied as a single-use indicator, packaged in packs of 24 bags, with each bag containing 250 strips. Because it is intended for one-time use, it cannot be reused after a single sterilization cycle. This design ensures accuracy and reliability for each cycle, as reuse could compromise the integrity of the indicator.

• Does the Cross-Checks device come sterile, and what standards does it meet?

  The Cross-Checks EO Integrator is supplied in a non-sterile form, meaning it is not pre-sterilized for clinical use. However, it complies with ISO 11140-1 standards for Type 4 indicators, which are designed to provide reliable visual confirmation of critical sterilization parameters in EO processes. This compliance ensures its accuracy in monitoring the sterilization cycle.

• What temperature range does the Cross-Checks device monitor, and why is this important?

  The Cross-Checks device is calibrated to monitor EO sterilization cycles within a temperature range of 132°C to 135°C (270°F–276°F). This range is critical because it falls within the validated parameters for effective EO sterilization, ensuring microbial lethality while preventing damage to heat-sensitive medical devices or instruments. The indicator confirms that the cycle stayed within this precise range.

• How do I determine which model or size of Cross-Checks is appropriate for my EO sterilizer?

  The Cross-Checks device is supplied in a standardized format—packs of 24 bags, each containing 250 strips—and is designed to be universally compatible with EO sterilizers operating within the specified temperature range (132°C–135°C). Since it is a single-use indicator, the choice depends solely on your sterilization cycle volume; simply select the quantity needed for your workload. No additional sizing or model selection is required beyond this, as the strips are interchangeable for monitoring.