510(k) · Cleared
Recalled · Class II · 2016Evotech Ecr
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 Dec 22, 2014 as substantially equivalent to K082392 (Advanced Sterilization Products, 2008) after a 250-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 22, 2014
- Review
- 250 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914145 (1994). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 3 generations backK040883 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005 · Recalled
- 2 generations backK061899 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · Recalled
- 1 generation backK082392 Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products · 2008 · Recalled
- This deviceK140977 Evotech EcrAdvanced Sterilization Products · 2014
- Descendant · cites it directly · 2 of its ownK152189 Evotech EcrAdvanced Sterilization Products (Asp) · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK230930 enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024
Most influential descendants
Showing 3 of 3 · See all- K152189Evotech EcrAdvanced Sterilization Products (Asp) · 2016 · cites it directly2descendants
- K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023 · 2 generations on1descendant
- K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| −3 | K040883 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2005 | 3 |
| −2 | K061899 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2006 | 2 |
| −1 | K082392 | Evotech Endoscope Cleaner and Reprocessor | Advanced Sterilization Products | 2008 | 3 |
| 0 (this device) | K140977 | Evotech Ecr | Advanced Sterilization Products | 2014 | — |
| +1 | K152189 | Evotech Ecr | Advanced Sterilization Products (Asp) | 2016 | 1 |
| +2 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | 2023 | — |
| +3 | 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 |
|---|---|---|
| 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 10.9 · 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 |
|---|---|---|---|
| * | K082392 | Evotech Endoscope Cleaner and ReprocessorSummary page 4…Product Code FEB) Product Classification: Class II 2. PREDICATE DEVICES EVOTECH® Integrated Washer Disinfector (K082392, cleared November 13, 2008) 3. DESCRIPTION OF DEVICE The EVOTECH® ECR Endoscope Cleaner & Reprocessor is a two-basi… | 2008 |
| † | K040883 | Evotech Integrated Endoscope Disinfection System | 2005 |
| † | K061889 | Biostar Oia Shigatox | 2006 |
| † | K991487 | Cidex Opa Solution | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152189 | Evotech Ecr | 2016 | 2 |
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. |
| May 11, 2015 | Class II | Z-1715-2015 | Nonconforming Material/Component | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if… |
| May 11, 2015 | Class II | Z-1714-2015 | Nonconforming Material/Component | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K152189 (Advanced Sterilization Products (Asp), 2016) has gone furthest, with 2 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. 2014, 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 EVOTECH® ECR 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® ECR 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/K140977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140977: Evotech Ecr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140977
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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