# K123768: Reliance Advance Endoscope Processing System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jul 26, 2013 after 231 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: 3 generations back to K914145 (1994). 6 ancestors in all.
2 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)
- K102244: Reliance Endoscope Processing System, STERIS Corporation (2010) Summary page 2.
- K061899: Evotech Integrated Endoscope Disinfection System, Advanced Sterilization Products (2006) Summary page 2.

## Most influential descendants
- K230560: enspire 300 Series Automated Endoscope Reprocessor System (2023), 1 descendant of its own
- K232918: enspire 300 Series Automated Endoscope Reprocessor (2023), 0 descendants of its own

## Indications for use
The Reliance Advance Endoscope Processing System is intended for cleaning and high level disinfection of up to two immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. During the system's standardized Endoscope Processing Cycle, cleaning is achieved within the Cleaning phase, and high level disinfection is achieved within the 50 - 57°C HLD phase (4 minute generation sequence followed by a 6-minute exposure sequence). Manual cleaning is not required prior to processing in Reliance Advance Endoscope Processing System.

Source page: https://510kreport.com/device/K123768
Methodology: https://510kreport.com/methodology