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System Ie Liquid Chemical Cterilant Processing System

by Steris Corporation

510(k) K101409

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 · Special NumberK101409 Date2 Aug 2010ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0616-2014 FDA Class II initiated 21 Nov 2013 on shared 510(k) K101409

    Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.

    • Terminated Z-2335-2012 FDA Class II initiated 1 Aug 2012

    The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.

    • Terminated Z-3124-2011 FDA Unclassified (pre-2012) initiated 11 Aug 2011 on shared 510(k) K101409

    STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.

    • Terminated Z-1960-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011

    The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to inco

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  • Withdrawn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 System 1E Liquid Chemical Sterilant Processing System is a medical device designed for liquid chemical sterilization. It processes instruments and devices using liquid chemical sterilants to achieve sterilization through chemical disinfection, ensuring compliance with hospital sterilization protocols for reusable medical items.

This system is intended for use in general hospital settings and is classified as a Class II medical device under FDA regulations. It is supplied as a reusable system requiring preventive maintenance inspections conducted quarterly, with specific inspections necessitating parts replacement annually. The device operates under FDA 510(k) clearance (K101409) and adheres to regulatory standards for liquid sterilants, ensuring safe and effective sterilization processes in clinical environments.

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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 System 1E Liquid Chemical Sterilant Processing System used for?

    The System 1E Liquid Chemical Sterilant Processing System is designed specifically for liquid chemical sterilization of reusable medical instruments and devices. It uses chemical disinfection to achieve sterilization, ensuring compliance with hospital sterilization protocols. This process is critical for maintaining safe and sterile conditions in general hospital settings where reusable medical items are reprocessed.

  • How is the System 1E Liquid Chemical Sterilant Processing System supplied and maintained?

    The System 1E is supplied as a reusable system, meaning it is intended for long-term use in clinical environments. To ensure continued safe and effective operation, it requires preventive maintenance inspections conducted quarterly. Additionally, certain inspections necessitate parts replacement annually, as part of the manufacturer’s recommended maintenance schedule.

  • Is the System 1E Liquid Chemical Sterilant Processing System single-use or reusable?

    The System 1E is a reusable device, not intended for single-use. Its design allows for repeated use in clinical settings, provided it undergoes regular preventive maintenance and required annual inspections to maintain performance and safety standards.

  • What regulatory clearance does the System 1E Liquid Chemical Sterilant Processing System hold?

    The System 1E Liquid Chemical Sterilant Processing System holds FDA 510(k) clearance under the reference number K101409. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and adheres to regulatory standards for liquid sterilants in medical settings.

  • What types of medical instruments can be processed using the System 1E?

    The System 1E is intended for processing reusable medical instruments and devices that require liquid chemical sterilization. While the exact range of compatible instruments is not specified in the provided data, it is designed to meet general hospital sterilization protocols, ensuring compatibility with common reusable medical items processed in such environments.