# K200989: Reliance Endoscope Processing System

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: May 14, 2020 after 29 days
- Product code: NZA (Accessories, Germicide, Cleaning, For Endoscopes)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K040049 (2004). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102244: Reliance Endoscope Processing System, STERIS Corporation (2010) Summary page 5.

## Most influential descendants
- K203223: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (2021), 1 descendant of its own
- K220361: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (2022), 0 descendants of its own

## Indications for use
The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50 – 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by the 6-minute exposure sequence).

Source page: https://510kreport.com/device/K200989
Methodology: https://510kreport.com/methodology