# K110453: Reliance Endoscope Processing System

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Mar 16, 2011 after 28 days
- Product code: NZA (Accessories, Germicide, Cleaning, For Endoscopes)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 3 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 2.

## Recalls of this device
- Aug 29, 2013 · Class II · Z-2263-2013: The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel

## 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 0 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/K110453
Methodology: https://510kreport.com/methodology