510(k) · Cleared
ClearedReliance EPS Endoscope Processing System and Reliance DG Dry Germicide
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 Mar 10, 2022 as substantially equivalent to K203223 (Steris, 2021) after a 30-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Mar 10, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- NZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040049 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK040049 The Reliance Endoscope Processing SystemSTERIS Corporation · 2004 · Recalled
- 3 generations backK102244 Reliance Endoscope Processing SystemSTERIS Corporation · 2010 · Recalled
- 2 generations backK200989 Reliance Endoscope Processing SystemSTERIS Corporation · 2020
- 1 generation backK203223 Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris · 2021
- This deviceK220361 Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSTERIS Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040049 | The Reliance Endoscope Processing System | STERIS Corporation | 2004 | 2 |
| −3 | K102244 | Reliance Endoscope Processing System | STERIS Corporation | 2010 | 1 |
| −2 | K200989 | Reliance Endoscope Processing System | STERIS Corporation | 2020 | — |
| −1 | K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | Steris | 2021 | — |
| 0 (this device) | K220361 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | STERIS Corporation | 2022 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSummary page 5…Cleaning, For Endoscopes Classification Number: 21 CFR 876.1500 Product Code: NZA 2. Predicate Device Reliance Endoscope Processing System, K203223 3. Description of Device The Reliance Endoscope Processing System is a high level disinfection system that can was… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2022, this device’s year, is highlighted.
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 bronchoscopes, GI flexible endoscopes including duodenoscopes, 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/K220361 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220361: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220361
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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