# K131078: System 1E Liquid Chemical Sterilant Processing System

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Jul 5, 2013 after 79 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K875280 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090036: System 1.5 Sterile Processing System, STERIS Corporation (2010) Summary page 2.
- K101409: System IE Liquid Chemical Cterilant Processing System, STERIS Corporation (2010) Summary page 2.
- K102462: System 1E Liquid Chemical Sterilant Processing System, STERIS Corporation (2010) Summary page 2.
- K113520: System 1E Liquid Chemical Sterilant Processing System, STERIS Corporation (2012)

## Recalls of this device
- Dec 4, 2015 · Class II · Z-1180-2016: The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processin
- Nov 21, 2013 · Class II · Z-0616-2014: 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 nuisa

## Indications for use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. *The extensive treatment of EPA potable water consists of: 1. Pre-filtration through two pre-filters: "Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants. "Pre-filter 2 is a surface filter that removes particles/contaminants >0.1 micron. 2. UV irradiation: *During transit through the UV water treatment chamber, a UV dose sufficient to achieve a >6-log reduction of MS2 virus is delivered to the water. 3. 0.1 micron filtration: *The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa >0.1 micron.

Source page: https://510kreport.com/device/K131078
Methodology: https://510kreport.com/methodology