# K040049: The Reliance Endoscope Processing System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Dec 17, 2004 after 340 days
- Product code: NZA (Accessories, Germicide, Cleaning, For Endoscopes)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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 its predicate without a number.
- (no number) Custom Ultrasonic System 83 Plus: named in the summary without a submission number
- (no number) STERIS 20 Sterilant Concentrate: named in the summary without a submission number
- (no number) Sterilox Liquid Chemical HLD System: named in the summary without a submission number

## Most influential descendants
- K102244: Reliance Endoscope Processing System (2010), 7 descendants of its own
- K200989: Reliance Endoscope Processing System (2020), 2 descendants of its own
- K123768: Reliance Advance Endoscope Processing System (2013), 2 descendants of its own
- K230560: enspire 300 Series Automated Endoscope Reprocessor System (2023), 1 descendant of its own
- K203223: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (2021), 1 descendant of its own

## 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
- Jul 2, 2010 · Not classified · Z-0823-2011: Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced.

## 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 Gl 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 a 6 minute exposure sequence).

Source page: https://510kreport.com/device/K040049
Methodology: https://510kreport.com/methodology