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Steris System 1 Processor and 20 Sterilant

by Steris C/O Medical Device Consultants, Inc.

510(k) K875280

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK875280 Date13 Sep 1988ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2462-2008 FDA Unclassified (pre-2012) initiated 4 Aug 2008

    During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top surface of bottom barb of the adapter. The interference may cause the plunger on the suction side to lift slightly which may affect flow of sterilant into the suction lumen.

    • Terminated Z-0765-04 FDA Unclassified (pre-2012) initiated 15 Mar 2004

    A defective port adapter may affect the sterilization process of the attached endoscope.

    • Terminated Z-0547-03 FDA Unclassified (pre-2012) initiated 7 Mar 2003 on shared 510(k) K875280

    The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MED
Device Class
Class II
Regulation
21 CFR Part 880.6885
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Steris System 1 Processor and Sterilant is a Liquid Chemical Sterilant Processing System designed for automated chemical sterilization of medical devices. It utilizes S40 Sterilant to achieve high-level disinfection and sterilization, targeting microbial contamination, including bacterial endospores, within device loads. The system is engineered to ensure thorough penetration of sterilant into complex geometries, such as port surfaces and lumens, which may be difficult to reach in other reprocessing methods.

This device is supplied as a reusable processor paired with a liquid chemical sterilant for automated use in healthcare settings. It is intended for general hospital applications and has received FDA 510K clearance under the Traditional pathway, classified as a Class II medical device. The system requires preventive maintenance and is not MRI-safe. No specific sterility or single-use designation is noted in the regulatory data, though the sterilant is applied in a controlled, automated process to ensure efficacy. Authorizations are tied to registration numbers and FEI numbers listed under the 880.6885 regulation.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Steris System 1 Processor and 20 Sterilant used for?

    The Steris System 1 Processor and 20 Sterilant is designed for automated chemical sterilization of medical devices in healthcare settings. It uses S40 Sterilant to achieve high-level disinfection and sterilization, targeting microbial contamination—including bacterial endospores—within device loads. The system is particularly effective for complex geometries like ports and lumens that may be difficult to sterilize using other methods.

  • How is the Steris System 1 Processor supplied, and is it reusable?

    The Steris System 1 Processor is supplied as a reusable automated device paired with a liquid chemical sterilant (S40 Sterilant). The processor itself is not single-use; it is intended for repeated use in healthcare environments, provided it undergoes required preventive maintenance to ensure proper function and sterility of reprocessed devices.

  • Is the Steris System 1 Processor sterile or single-use?

    The Steris System 1 Processor is not designated as sterile or single-use in the regulatory data. Instead, the sterilant (S40) is applied in a controlled, automated process within the system to ensure the efficacy of sterilization for medical devices. The processor itself is reusable, but its performance depends on proper maintenance and adherence to the manufacturer’s guidelines.

  • What types of medical devices can be sterilized using the Steris System 1 Processor?

    The Steris System 1 Processor is intended for general hospital applications, meaning it can be used to sterilize a wide range of medical devices commonly found in healthcare settings. This includes devices with complex geometries, such as those with ports, lumens, or intricate surfaces, where thorough sterilant penetration is critical to ensure microbial elimination.

  • Does the Steris System 1 Processor require any special storage or maintenance?

    Yes, the Steris System 1 Processor requires preventive maintenance to ensure its continued functionality and the sterility of reprocessed devices. While the regulatory data does not specify storage conditions beyond typical healthcare environments, adherence to the manufacturer’s maintenance protocols—such as cleaning, calibration, and part replacement—is essential to maintain performance and compliance with sterilization standards.