510(k) · Cleared
Recalled · Class II · 2021ENDOSCOPE 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 Jul 9, 2019 as substantially equivalent to K103264 (Olympus Medical Systems Corporation, 2011) after an 88-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 9, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914145 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 2 generations backK093106 Endoscope Reprocessor Oer-ProOlympus Medical Systems Corporation · 2010
- 1 generation backK103264 Endoscope Reprocessor Oer-Pro Model Oer-ProOlympus Medical Systems Corporation · 2011 · Recalled
- This deviceK190969 ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 0 of its ownK201920 Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp. · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| −2 | K093106 | Endoscope Reprocessor Oer-Pro | Olympus Medical Systems Corporation | 2010 | — |
| −1 | K103264 | Endoscope Reprocessor Oer-Pro Model Oer-Pro | Olympus Medical Systems Corporation | 2011 | 6 |
| 0 (this device) | K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K201920 | Endoscope Reprocessor OER-Elite | Olympus Medical Systems Corp. | 2020 | 16 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K103264 | Endoscope Reprocessor Oer-Pro Model Oer-ProSummary page 4…hed under Section 514 of FD&C Act. Predicate Device (PD) Device Trade Name ENDOSCOPE REPROCESSOR OER-Pro 510(k) Number K103264 Manufacturer AIZU OLYMPUS CO., LTD. Olympus Corporation of the America… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201920 | Endoscope Reprocessor OER-Elite | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K201920 (Olympus Medical Systems Corp., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K103264.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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/K190969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190969: ENDOSCOPE REPROCESSOR OER-Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190969
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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