# K161683: SYSTEM 1E Liquid Chemical Sterilant Processing System

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Aug 5, 2016 after 49 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
No predicates in its family tree.
15 later devices descend from it; 1 cites 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K170956: SYSTEM 1E Liquid Chemical Sterilant Processing System (2017), 14 descendants of its own
- 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

## 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/K161683
Methodology: https://510kreport.com/methodology