# K170956: SYSTEM 1E Liquid Chemical Sterilant Processing System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Sep 22, 2017 after 175 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K161683 (2016). 1 ancestor in all.
14 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161683: SYSTEM 1E Liquid Chemical Sterilant Processing System, STERIS Corporation (2016) Summary page 5.

## Most influential descendants
- K173256: System 1 endo Liquid Chemical Sterilant Processing System (2018), 12 descendants of its own
- K182827: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (2019), 10 descendants of its own
- K180342: SYSTEM 1E Liquid Chemical Sterilant Processing System (2018), 10 descendants of its own
- K191343: SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (2019), 9 descendants of its own
- K190104: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System (2019), 9 descendants of its own

## 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 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. 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 A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants. • Pre-filter B 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/K170956
Methodology: https://510kreport.com/methodology