510(k) · Cleared

Recalled · Class II · 2013

Reliance Endoscope Processing System

K110453510(k) SpecialCleared Mar 16, 201128-day reviewClass II21 CFR 876.1500Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

STERIS Corporation · NZA Accessories, Germicide, Cleaning, For Endoscopes

Cleared on Mar 16, 2011 as substantially equivalent to K102244 (STERIS Corporation, 2010) after a 28-day review. Its family tree reaches back 2 generations to 2004. It has been recalled once.

Decided: Mar 16, 2011
Review: 28 days
Class: Class II
Product code: NZA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K040049 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK040049 The Reliance Endoscope Processing SystemSTERIS Corporation · 2004 · Recalled
1 generation backK102244 Reliance Endoscope Processing SystemSTERIS Corporation · 2010 · Recalled
This deviceK110453 Reliance Endoscope Processing SystemSTERIS Corporation · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K040049	The Reliance Endoscope Processing System	STERIS Corporation	2004	2
−1	K102244	Reliance Endoscope Processing System	STERIS Corporation	2010	1
0 (this device)	K110453	Reliance Endoscope Processing System	STERIS Corporation	2011	—

FIG. 1 — Lineage of K110453, 2004–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NZA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NZA device

#1 K230560 enspire 300 Series Automated Endoscope…score 9.6 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K102244	Reliance Endoscope Processing System Summary page 2 …cation Name: 21 CFR 876.1500 Endoscope and Accessories 2. Predicate Device Reliance Endoscope Processing System K102244 3. Description of Device The Reliance Endoscope Processing System is an economical, easy-to-use high level disinfec…	STERIS Corporation	2010	1

Also cleared against K102244: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 29, 2013	Class II	Z-2263-2013	Use error	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 within the light guide (LG)…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 6.0 years on median.
2 of the 2 ancestors have a recall of any class.
2 other devices also cite its predicate K102244.

How does its category compare?

All NZA devices

NZA Accessories, Germicide, Cleaning, For Endoscopes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NZA

2in 2023

2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NZA

Too few NZA 510(k)s in any year since 2007 to give a median.

Recalls per year · NZA

No recall names NZA since 2007.

Adverse event reports per year · NZA

2in 2022

2007high 21 (2016) · low 0 (2007)2025

MAUDE reports naming product code NZA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	1
2011	1	—	1
2012	0	—	14
2013	1	—	11
2014	0	—	6
2015	0	—	10
2016	0	—	21
2017	0	—	9
2018	0	—	8
2019	0	—	2
2020	1	—	1
2021	1	—	4
2022	1	—	2
2023	2	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110453 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110453: Reliance Endoscope Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110453

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026