SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K251666 ↗

FDA product code

MED

Models / Variants

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Device class

Class II

Regulation

21 CFR Part 880.6885

Advisory committee

General Hospital

FDA decision

SESE Substantially Equivalent

• Snowden-Pencer 886122V

  Class I

  GUDID on market

• Snowden-Pencer 886118V

  Class I

  GUDID on market

• Snowden-Pencer 886127V

  Class I

  GUDID on market

• V. Mueller NL1060

  Class I

  GUDID on market

• V. Mueller NL1064

  Class I

  GUDID on market

• V. Mueller NL1073

  Class I

  GUDID on market

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• Are these systems compatible with MRI environments, and if not, why should I avoid using them there?

  No, the SYSTEM 1E (Model P6700) and SYSTEM 1 endo (Model P6900) are explicitly not intended for MRI environments. This is because the systems contain metallic components and use liquid chemical sterilants that could interfere with MRI imaging or pose safety risks in strong magnetic fields. Always verify the environment before use to ensure compliance with facility protocols and patient safety.

• How are these sterilization systems maintained between uses, and what does that involve?

  The SYSTEM 1E and SYSTEM 1 endo are reusable equipment, requiring proper maintenance and sterilization between cycles. This includes cleaning, disinfection, and validation of the sterilization process to ensure the system itself remains free of microbial contamination. Steris provides maintenance protocols, but facilities must follow these guidelines to comply with regulatory standards and maintain device efficacy.

• What types of medical devices can be processed using these systems, and are there any restrictions?

  These systems are designed for processing medical devices in hospital environments, targeting bacterial endospores and other microbial contaminants. While the exact device types aren’t specified in the data, they are not intended for use with devices incompatible with liquid chemical sterilants (e.g., those with porous materials that may absorb residues or materials that degrade in the process). Always consult the manufacturer’s instructions for specific device compatibility.

• How do I know if these systems are appropriate for my hospital’s needs, given their regulatory classification?

  These systems are classified as Class II medical devices under FDA regulations and were granted 510(k) clearance (K251666) as substantially equivalent to a predicate device. They are registered for use in general hospital settings, meaning they are suitable for most healthcare facilities processing reusable medical devices via liquid chemical sterilization. Verify your facility’s specific workflows and device types to ensure alignment with the system’s intended use.

• Are there any special storage requirements for these systems when not in use?

  While the data doesn’t specify exact storage conditions, reusable medical devices like these typically require clean, dry, and protected environments to prevent contamination or damage. Ensure the systems are stored in a designated area away from direct sunlight, extreme temperatures, or sources of moisture. Follow Steris’s maintenance guidelines to preserve functionality and sterility between uses.