# K173256: System 1 endo Liquid Chemical Sterilant Processing System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Mar 2, 2018 after 143 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: 2 generations back to K161683 (2016). 2 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170956: SYSTEM 1E Liquid Chemical Sterilant Processing System, STERIS Corporation (2017) Summary page 5.

## Most influential descendants
- K182827: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (2019), 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
- K192929: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (2019), 8 descendants of its own
- K210737: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate (2021), 7 descendants of its own

## Indications for use
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

Source page: https://510kreport.com/device/K173256
Methodology: https://510kreport.com/methodology