510(k) · Cleared
Recalled · Class II · 2016Evotech Endoscope Cleaner and Reprocessor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · FEB Accessories, Cleaning, For Endoscope
Cleared on Nov 13, 2008 as substantially equivalent to K061899 (Advanced Sterilization Products, 2006) after an 86-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 13, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914145 (1994). 4 ancestors in all. 4 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 deviceK082392 Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products · 2008
- Descendant · cites it directly · 3 of its ownK140977 Evotech EcrAdvanced Sterilization Products · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK152189 Evotech EcrAdvanced Sterilization Products (Asp) · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK230930 enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023
- Descendant · 4 generations on · 0 of its ownK243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024
Most influential descendants
Showing 4 of 4 · See all- K140977Evotech EcrAdvanced Sterilization Products · 2014 · cites it directly3descendants
- K152189Evotech EcrAdvanced Sterilization Products (Asp) · 2016 · 2 generations on2descendants
- K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023 · 3 generations on1descendant
- K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024 · 4 generations on0descendants
View 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) | K082392 | Evotech Endoscope Cleaner and Reprocessor | Advanced Sterilization Products | 2008 | — |
| +1 | K140977 | Evotech Ecr | Advanced Sterilization Products | 2014 | 3 |
| +2 | K152189 | Evotech Ecr | Advanced Sterilization Products (Asp) | 2016 | 1 |
| +3 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | 2023 | — |
| +4 | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 FEB? 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 FEB device
- #1 K243433 enspire 3000 Cleaning and Liquid Chemical…score 10.8 · 9 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 |
|---|---|---|---|
| * | K061899 | Evotech Integrated Endoscope Disinfection SystemSummary page 1…Washer Disinfector Classification Class II Legally Marketed Equivalent Device EVOTECH TmEndoscope Cleaner and Reprocessor (K06 1899) Description of Device The EVOTECH Tm Endoscope Cleaner and Re-processor was cleared under the Premar… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140977 | Evotech Ecr | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2016 | Class II | Z-0965-2017 | Nonconforming Material/Component | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak. |
| Mar 28, 2013 | Class II | Z-1150-2013 | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel… |
| Mar 22, 2013 | Class II | Z-1123-2013 | Nonconforming Material/Component | Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K140977 (Advanced Sterilization Products, 2014) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K061899.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FEB
111in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEB
15so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEB
356in 2025
MAUDE reports naming product code FEB, 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 | 2 | — | 0 | 39 |
| 2008 | 1 | — | 3 | 152 |
| 2009 | 1 | — | 0 | 20 |
| 2010 | 2 | — | 1 | 50 |
| 2011 | 3 | 111 | 0 | 32 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 27 |
| 2014 | 1 | — | 0 | 48 |
| 2015 | 0 | — | 0 | 92 |
| 2016 | 2 | — | 2 | 103 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 2 | — | 0 | 62 |
| 2020 | 2 | — | 1 | 426 |
| 2021 | 0 | — | 1 | 575 |
| 2022 | 1 | — | 0 | 607 |
| 2023 | 1 | — | 1 | 998 |
| 2024 | 2 | — | 1 | 884 |
| 2025 | 0 | — | 3 | 356 |
| 2026 | 1 | — | 15 | — |
What is it indicated for?
The EVOTECHTM Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60 0C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082392 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082392: Evotech Endoscope Cleaner and Reprocessor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082392
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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