510(k) · Cleared
Recalled · Class II · 2026Endoscope Reprocessor OER-Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · FEB Accessories, Cleaning, For Endoscope
Cleared on Sep 1, 2020 as substantially equivalent to K190969 (Olympus Medical Systems Corp., 2019) after a 53-day review. Its family tree reaches back 4 generations to 1994. It has been recalled 16 times.
- Decided
- Sep 1, 2020
- Review
- 53 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 16
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914145 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 3 generations backK093106 Endoscope Reprocessor Oer-ProOlympus Medical Systems Corporation · 2010
- 2 generations backK103264 Endoscope Reprocessor Oer-Pro Model Oer-ProOlympus Medical Systems Corporation · 2011 · Recalled
- 1 generation backK190969 ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · 2019 · Recalled
- This deviceK201920 Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp. · 2020
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 | K093106 | Endoscope Reprocessor Oer-Pro | Olympus Medical Systems Corporation | 2010 | — |
| −2 | K103264 | Endoscope Reprocessor Oer-Pro Model Oer-Pro | Olympus Medical Systems Corporation | 2011 | 6 |
| −1 | K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Olympus Medical Systems Corp. | 2019 | 1 |
| 0 (this device) | K201920 | Endoscope Reprocessor OER-Elite | Olympus Medical Systems Corp. | 2020 | — |
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 |
|---|---|---|---|
| * | K190969 | ENDOSCOPE REPROCESSOR OER-EliteSummary page 5…Device name 510(k) Submitter 510(k) No. ENDOSCOPE REPROCESSOR OLYMPUS MEDICAL K190969 OER-Elite SYSTEMS CORP. 4. DEVICE DESCRIPTION General Description of the subject device… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2026 | Class II | Z-1903-2026 | Device Design | XXX |
| Mar 25, 2026 | Class II | Z-1905-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1906-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1902-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1904-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1900-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1898-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1908-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1899-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1901-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1909-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Mar 25, 2026 | Class II | Z-1907-2026 | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Feb 12, 2026 | Class II | Z-1612-2026 | Reprocessing Controls | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
| Oct 31, 2025 | Class II | Z-0872-2026 | Under Investigation by firm | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. |
| May 26, 2023 | Class II | Z-2344-2023 | Labeling Change Control | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as… |
| Dec 13, 2021 | Class II | Z-0638-2022 | Process control | The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed… |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a…
Read the full statement (121 words)
The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201920: Endoscope Reprocessor OER-Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201920
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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