510(k) · Cleared
Recalled · Class II · 2013Reliance 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 3, 2010 as substantially equivalent to K040049 (STERIS Corporation, 2004) after a 116-day review. Its family tree reaches back 1 generation to 2004. 7 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 2010
- Review
- 116 days
- Class
- Class II
- Product code
- NZA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040049 (2004). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK040049 The Reliance Endoscope Processing SystemSTERIS Corporation · 2004 · Recalled
- This deviceK102244 Reliance Endoscope Processing SystemSTERIS Corporation · 2010
- Descendant · cites it directly · 2 of its ownK200989 Reliance Endoscope Processing SystemSTERIS Corporation · 2020
- Descendant · cites it directly · 2 of its ownK123768 Reliance Advance Endoscope Processing SystemSTERIS Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK230560 enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK203223 Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris · 2021
- Descendant · 3 generations on · 0 of its ownK232918 enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200989Reliance Endoscope Processing SystemSTERIS Corporation · 2020 · cites it directly2descendants
- K123768Reliance Advance Endoscope Processing SystemSTERIS Corporation · 2013 · cites it directly2descendants
- K230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation · 2023 · 2 generations on1descendant
- K203223Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris · 2021 · 2 generations on1descendant
- K232918enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040049 | The Reliance Endoscope Processing System | STERIS Corporation | 2004 | 2 |
| 0 (this device) | K102244 | Reliance Endoscope Processing System | STERIS Corporation | 2010 | — |
| +1 | K200989 | Reliance Endoscope Processing System | STERIS Corporation | 2020 | — |
| +1 | K123768 | Reliance Advance Endoscope Processing System | STERIS Corporation | 2013 | — |
| +2 | K230560 | enspire 300 Series Automated Endoscope Reprocessor System | STERIS Corporation | 2023 | — |
| +2 | K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | Steris | 2021 | — |
| +3 | K232918 | enspire 300 Series Automated Endoscope Reprocessor | STERIS Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K040049 | The Reliance Endoscope Processing SystemSummary page 2…21 CFR 876.1500 Endoscope Cleaning Germicide Accessories 2. Predicate Device Reliance Endoscope Processing System K040049 3. Description of Device The Reliance Endoscope Processing System is an economical, easy-to-use high level disinfec… | 2004 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has a recall.
- Of its descendants, K200989 (STERIS Corporation, 2020) has gone furthest, with 2 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. 2010, 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 GI 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 as stated in the FDA summary.
https://510kreport.com/device/K102244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102244: 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/K102244
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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