# K220361: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Mar 10, 2022 after 30 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: 4 generations back to K040049 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203223: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide, Steris (2021) Summary page 5.

## 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 bronchoscopes, GI flexible endoscopes including duodenoscopes, 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 a 6-minute exposure sequence).

Source page: https://510kreport.com/device/K220361
Methodology: https://510kreport.com/methodology