510(k) · Cleared
Recalled · Class II · 2026Endoscope Reprocessor Oer-Pro Model Oer-Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · FEB Accessories, Cleaning, For Endoscope
Cleared on Feb 23, 2011 as substantially equivalent to K093106 (Olympus Medical Systems Corporation, 2010) after a 111-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 23, 2011
- Review
- 111 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914145 (1994). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 1 generation backK093106 Endoscope Reprocessor Oer-ProOlympus Medical Systems Corporation · 2010
- This deviceK103264 Endoscope Reprocessor Oer-Pro Model Oer-ProOlympus Medical Systems Corporation · 2011
- Descendant · cites it directly · 1 of its ownK190969 ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK201920 Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp. · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK181472 AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC…Advanced Sterilization Products (Asp) · 2019
- Descendant · cites it directly · 0 of its ownK120357 Endoscope Reprocessor Oer-MiniOlympus Medical Systems Corp. · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · 2019 · cites it directly1descendant
- K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp. · 2020 · 2 generations on0descendants
- K181472AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC MonitorAdvanced Sterilization Products (Asp) · 2019 · cites it directly0descendants
- K120357Endoscope Reprocessor Oer-MiniOlympus Medical Systems Corp. · 2012 · cites it directly0descendants
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 | K093106 | Endoscope Reprocessor Oer-Pro | Olympus Medical Systems Corporation | 2010 | — |
| 0 (this device) | K103264 | Endoscope Reprocessor Oer-Pro Model Oer-Pro | Olympus Medical Systems Corporation | 2011 | — |
| +1 | K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Olympus Medical Systems Corp. | 2019 | 1 |
| +2 | K201920 | Endoscope Reprocessor OER-Elite | Olympus Medical Systems Corp. | 2020 | 16 |
| +1 | K181472 | AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor | Advanced Sterilization Products (Asp) | 2019 | — |
| +1 | K120357 | Endoscope Reprocessor Oer-Mini | Olympus Medical Systems Corp. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 2 | 0 |
| 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 10.8 · 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 |
|---|---|---|---|
| * | K093106 | Endoscope Reprocessor Oer-ProSummary page 1…under Section 514 of FD&C Act. u Predicate Device (PD) * Device Trade Name ENDOSCOPE REPROCESSOR OER-Pro * 5 10(k) Number K093106 * Manufacturer AIZU OLYMPUS CO., LTD. OLYMPUS AMERICA INC.… | 2010 |
What descends from it? (4)
3 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 12, 2026 | Class II | Z-1613-2026 | 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-0873-2026 | 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. |
| Jan 16, 2024 | Class II | Z-1009-2024 | Process control | Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis. |
| Jul 12, 2023 | Class II | Z-2447-2023 | Under Investigation by firm | The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow… |
| May 26, 2023 | Class II | Z-2342-2023 | 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… |
| Jun 23, 2016 | Class II | Z-0138-2017 | Under Investigation by firm | New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and… |
The 5 latest of 6 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 17 years and passes through 2 companies; a new generation was cleared every 16.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K190969 (Olympus Medical Systems Corp., 2019) 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. 2011, 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-Pro is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their 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-Pro and Olympus flexible endoscopes and their accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by…
Read the full statement (117 words)
The OER-Pro is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their 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-Pro and Olympus flexible endoscopes and their 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-Pro components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Pro enables the user to performu modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Pro.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103264: Endoscope Reprocessor Oer-Pro Model Oer-Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103264
Report an extraction error
Are you the manufacturer?
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