510(k) · Cleared
Recalled · 2008Evotech 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 Oct 26, 2006 as substantially equivalent to K040883 (Advanced Sterilization Products, 2005) after a 115-day review. Its family tree reaches back 2 generations to 1994. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 26, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914145 (1994). 3 ancestors in all. 17 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 1 generation backK040883 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005 · Recalled
- This deviceK061899 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006
- Descendant · cites it directly · 7 of its ownK082988 Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA…Medivators Reprocessing Systems · 2009 · Recalled
- Descendant · cites it directly · 4 of its ownK082392 Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products · 2008 · Recalled
- Descendant · 2 generations on · 3 of its ownK140977 Evotech EcrAdvanced Sterilization Products · 2014 · Recalled
- Descendant · 3 generations on · 2 of its ownK152189 Evotech EcrAdvanced Sterilization Products (Asp) · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK152394 Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K082988Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Medivators Reprocessing Systems · 2009 · cites it directly7descendants
- K082392Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products · 2008 · cites it directly4descendants
- K140977Evotech EcrAdvanced Sterilization Products · 2014 · 2 generations on3descendants
- K152189Evotech EcrAdvanced Sterilization Products (Asp) · 2016 · 3 generations on2descendants
- K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| −1 | K040883 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2005 | 3 |
| 0 (this device) | K061899 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2006 | — |
| +1 | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High… | Medivators Reprocessing Systems | 2009 | 4 |
| +1 | K082392 | Evotech Endoscope Cleaner and Reprocessor | Advanced Sterilization Products | 2008 | 3 |
| +2 | K140977 | Evotech Ecr | Advanced Sterilization Products | 2014 | 3 |
| +3 | K152189 | Evotech Ecr | Advanced Sterilization Products (Asp) | 2016 | 1 |
| +2 | K152394 | Rapicide PA High-Level Disinfectant Test Strips | Medivators, Inc. | 2016 | — |
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 |
|---|---|---|
| 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 10.9 · 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 |
|---|---|---|---|
| * | K040883 | Evotech Integrated Endoscope Disinfection SystemSummary page 1…em Classification: Endoscopes and accessories Predicate Device: The EvoTechTM System claims equivalence to the EvoTechTM System (K040883) found substantially equivalent on April 5, 2005. The predicate device is cleared to high-level disinfect endoscopes tha… | 2005 |
What descends from it? (17)
See all 174 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 |
|---|---|---|---|---|
| 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K082988 (Medivators Reprocessing Systems, 2009) has gone furthest, with 7 descendants of its own.
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 TM System, 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 (>600 C) 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 is required when selecting the Disinfect Only or Disinfect/Alcohol Flush Cycles.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061899: Evotech Integrated Endoscope Disinfection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061899
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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