# K090036: System 1.5 Sterile Processing System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Apr 5, 2010 after 454 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K875280 (1988). 7 ancestors in all.
4 later devices descend from it; 4 cite 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)
- K875280: Steris System 1 Processor and 20 Sterilant, Steris C/O Medical Device Consultants, Inc. (1988) Summary page 3.
- K013280: Sterilox Liquid Chemical Sterilant System, Sterilox Technologies, Inc. (2002) Summary page 3.

## Most influential descendants
- K101409: System IE Liquid Chemical Cterilant Processing System (2010), 3 descendants of its own
- K102462: System 1E Liquid Chemical Sterilant Processing System (2010), 2 descendants of its own
- K113520: System 1E Liquid Chemical Sterilant Processing System (2012), 1 descendant of its own
- 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
- Aug 10, 2012 · Class II · Z-2284-2012: STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models 
- Aug 1, 2012 · Class II · Z-2335-2012: 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
- Dec 7, 2011 · Not classified · Z-0869-2012: Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and wa
- Aug 11, 2011 · Not classified · Z-3124-2011: STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.
- Mar 14, 2011 · Not classified · Z-1960-2011: 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 abo

## 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 IE 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 550C, and rinses the load with extensively treated* potable water. The processed load should be used immediately. The SYSTEM I E 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 > 0.1I 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. 0.1I micron filtration: * The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1I-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1I micron.

Source page: https://510kreport.com/device/K090036
Methodology: https://510kreport.com/methodology