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 (Asp) · FEB Accessories, Cleaning, For Endoscope
Cleared on Jul 20, 2016 as substantially equivalent to K140977 (Advanced Sterilization Products, 2014) after a 350-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 20, 2016
- Review
- 350 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914145 (1994). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 4 generations backK040883 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005 · Recalled
- 3 generations backK061899 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · Recalled
- 2 generations backK082392 Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products · 2008 · Recalled
- 1 generation backK140977 Evotech EcrAdvanced Sterilization Products · 2014 · Recalled
- This deviceK152189 Evotech EcrAdvanced Sterilization Products (Asp) · 2016
- Descendant · cites it directly · 1 of its ownK230930 enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024
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 |
|---|---|---|---|---|---|
| −5 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| −4 | K040883 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2005 | 3 |
| −3 | K061899 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2006 | 2 |
| −2 | K082392 | Evotech Endoscope Cleaner and Reprocessor | Advanced Sterilization Products | 2008 | 3 |
| −1 | K140977 | Evotech Ecr | Advanced Sterilization Products | 2014 | 3 |
| 0 (this device) | K152189 | Evotech Ecr | Advanced Sterilization Products (Asp) | 2016 | — |
| +1 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | 2023 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K140977 | Evotech EcrSummary page 4…Product Code FEB Product Classification: Class II 510(k) Number: K152189 III. PREDICATE DEVICE EVOTECH® ECR Endoscope Cleaner and Reprocessor (K140977) IV. DESCRIPTION OF DEVICE The EVOTECH® ECR Endoscope Cleaner and Reprocessor is a two-basin washer/disinfector… | 2014 |
| † | K040883 | Evotech Integrated Endoscope Disinfection System | 2005 |
| † | K061889 | Biostar Oia Shigatox | 2006 |
| † | K991487 | Cidex Opa Solution | 1999 |
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 |
|---|---|---|---|
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | 2023 | 1 |
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K230930 (STERIS Corporation, 2023) has gone furthest, with 1 descendant 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. 2016, 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 Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR Endoscope Cleaner and Reprocessor 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/K152189 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152189: Evotech Ecr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152189
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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