# K113520: System 1E Liquid Chemical Sterilant Processing System

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Feb 21, 2012 after 84 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: 6 generations back to K875280 (1988). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K131078: System 1E Liquid Chemical Sterilant Processing System (2013), 0 descendants of its own

## Recalls of this device
- 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
- Mar 4, 2013 · Class II · Z-1596-2013: During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted th

## Indications for use
The SYSTEM IE 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 IFE Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1 820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 550 C, and rinses the load with extensively treated* potable water. The processed load should be used immediately. The SYSTEM IFE 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 I 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 isdelivered 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/K113520
Methodology: https://510kreport.com/methodology