510(k) · Cleared
Recalled · Class II · 2016Evotech Integrated Endoscope Disinfection System
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 Mar 15, 2005 as substantially equivalent to K914145 (Medivators, Inc., 1994) and 1 other predicate after a 344-day review. Its family tree reaches back 1 generation to 1994. 18 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 15, 2005
- Review
- 344 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914145 (1994). 2 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- This deviceK040883 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005
- Descendant · cites it directly · 17 of its ownK061899 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · Recalled
- Descendant · 2 generations on · 7 of its ownK082988 Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA…Medivators Reprocessing Systems · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK082392 Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products · 2008 · Recalled
- Descendant · 3 generations on · 3 of its ownK140977 Evotech EcrAdvanced Sterilization Products · 2014 · Recalled
- Descendant · 4 generations on · 2 of its ownK152189 Evotech EcrAdvanced Sterilization Products (Asp) · 2016 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K061899Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · cites it directly17descendants
- K082988Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Medivators Reprocessing Systems · 2009 · 2 generations on7descendants
- K082392Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products · 2008 · 2 generations on4descendants
- K140977Evotech EcrAdvanced Sterilization Products · 2014 · 3 generations on3descendants
- K152189Evotech EcrAdvanced Sterilization Products (Asp) · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| 0 (this device) | K040883 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2005 | — |
| +1 | K061899 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2006 | 2 |
| +2 | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High… | Medivators Reprocessing Systems | 2009 | 4 |
| +2 | K082392 | Evotech Endoscope Cleaner and Reprocessor | Advanced Sterilization Products | 2008 | 3 |
| +3 | K140977 | Evotech Ecr | Advanced Sterilization Products | 2014 | 3 |
| +4 | K152189 | Evotech Ecr | Advanced Sterilization Products (Asp) | 2016 | 1 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914145 | DSD-91(TM) Disinfector for Flexible EndoscopesSummary page 1…e: EvoTech 'm Integrated Endoscope Disinfection System Legally marketed The EvoTech System claims equivalence to the Medivators DSD-91 device Disinfector (K914145). The predicate is a system that utilizes a sterilant / high level disinfectant solution to reprocess reusable… | 1994 |
| Kept off the family tree | K032959 | FDA’s K032959 is Cidex Opa Concentrate Our reading of the summary gave K032959, which FDA decided on Apr 4, 2005, after this device was decided (Mar 15, 2005), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1…he EvoTechTM System is a two-basin washer / disinfector utilizing a description concentrated high-level disinfectant (CIDEX ® OPA Concentrate - K032959) that is diluted within the system to an In-Use concentration. The system performs a leak test, a block test,… | 2005 |
| * | K991487 | Cidex Opa SolutionSummary page 2…icles. The effects seen were similar to those seen with the predicate device for the high level disinfectant - CIDEX OPA Solution K99 1487. Stability N/A Conclusion The data presented and the equivalence demonstrated to the predicate… | 1999 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061899 | Evotech Integrated Endoscope Disinfection System | 2006 | 17 |
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. |
| Feb 13, 2008 | Not classified | Z-1369-2008 | Other | Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid opening, and c) Minor… |
| Feb 13, 2008 | Not classified | Z-1368-2008 | Other | Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid opening, and c) Minor… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 EvoTech System, a washer / disinfector, is indicated for use with the high
level disinfectant CIDEX® OPA Concentrate, (MEC of 0.055%, minimum
temperature of 500 C for a contact time of 5 minutes) for reprocessing heat
sensitive (<60 0C) semi critical endoscopes. Endoscopes must be manually
cleaned prior to placement in the EvoTech System.
The System includes an on-board MEC monitor, performs automated leak test,
block test and post processing alcohol flush.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040883: Evotech Integrated Endoscope Disinfection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040883
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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