510(k) · Cleared
Recalled · Class II · 2013The Reliance Endoscope Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · NZA Accessories, Germicide, Cleaning, For Endoscopes
Cleared on Dec 17, 2004 after a 340-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 17, 2004
- Review
- 340 days
- Class
- Class II
- Product code
- NZA
- Recalls
- 2
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK040049 The Reliance Endoscope Processing SystemSTERIS Corporation · 2004
- Descendant · cites it directly · 7 of its ownK102244 Reliance Endoscope Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK200989 Reliance Endoscope Processing SystemSTERIS Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK123768 Reliance Advance Endoscope Processing SystemSTERIS Corporation · 2013
- Descendant · 3 generations on · 1 of its ownK230560 enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation · 2023
- Descendant · 3 generations on · 1 of its ownK203223 Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K102244Reliance Endoscope Processing SystemSTERIS Corporation · 2010 · cites it directly7descendants
- K200989Reliance Endoscope Processing SystemSTERIS Corporation · 2020 · 2 generations on2descendants
- K123768Reliance Advance Endoscope Processing SystemSTERIS Corporation · 2013 · 2 generations on2descendants
- K230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation · 2023 · 3 generations on1descendant
- K203223Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040049 | The Reliance Endoscope Processing System | STERIS Corporation | 2004 | — |
| +1 | K102244 | Reliance Endoscope Processing System | STERIS Corporation | 2010 | 1 |
| +2 | K200989 | Reliance Endoscope Processing System | STERIS Corporation | 2020 | — |
| +2 | K123768 | Reliance Advance Endoscope Processing System | STERIS Corporation | 2013 | — |
| +3 | K230560 | enspire 300 Series Automated Endoscope Reprocessor System | STERIS Corporation | 2023 | — |
| +3 | K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | Steris | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | — | Custom Ultrasonic System 83 Plus Named without a submission number | |
| * | — | STERIS 20 Sterilant Concentrate Named without a submission number | |
| * | — | Sterilox Liquid Chemical HLD System Named without a submission number | |
| † | K921559 | STERIS PROCESS Indicator Chemical Monitor |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102244 | Reliance Endoscope Processing System | 2010 | 7 |
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)… |
| Jul 2, 2010 | Not classified | Z-0823-2011 | Other | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K102244 (STERIS Corporation, 2010) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NZA devicesNZA Accessories, Germicide, Cleaning, For Endoscopes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NZA
2in 2023
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 1 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 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 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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040049: The Reliance Endoscope Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040049
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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