510(k) · Cleared
ClearedReliance Advance 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 Jul 26, 2013 as substantially equivalent to K102244 (STERIS Corporation, 2010) and 1 other predicate after a 231-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 26, 2013
- Review
- 231 days
- Class
- Class II
- Product code
- NZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K914145 (1994). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 2 generations backK040883 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005 · Recalled
- 1 generation backK061899 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · Recalled
- This deviceK123768 Reliance Advance Endoscope Processing SystemSTERIS Corporation · 2013
- Descendant · cites it directly · 1 of its ownK230560 enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK232918 enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| −2 | K040883 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2005 | 3 |
| −1 | K061899 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2006 | 2 |
| 0 (this device) | K123768 | Reliance Advance Endoscope Processing System | STERIS Corporation | 2013 | — |
| +1 | K230560 | enspire 300 Series Automated Endoscope Reprocessor System | STERIS Corporation | 2023 | — |
| +2 | K232918 | enspire 300 Series Automated Endoscope Reprocessor | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K102244 | Reliance Endoscope Processing SystemSummary page 2…ories Device Class: 11 Product Code: NZA 2. Predicate Device Reliance Endoscope Processing System (EPS) - K 102244 EVOTECH Endoscope Cleaner and Reprocessor (ECR) - K061 899 3. Description of Device The Reliance Advance Endo… | 2010 |
| * | K061899 | Evotech Integrated Endoscope Disinfection SystemSummary page 2…de: NZA 2. Predicate Device Reliance Endoscope Processing System (EPS) - K 102244 EVOTECH Endoscope Cleaner and Reprocessor (ECR) - K061 899 3. Description of Device The Reliance Advance Endoscope Processing System is an economical, easy-to-use clean… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230560 | enspire 300 Series Automated Endoscope Reprocessor System | 2023 | 1 |
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 19 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K230560 (STERIS Corporation, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K102244.
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. 2013, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123768 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123768: Reliance Advance Endoscope Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123768
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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