# K103264: Endoscope Reprocessor Oer-Pro Model Oer-Pro

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Feb 23, 2011 after 111 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914145 (1994). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093106: Endoscope Reprocessor Oer-Pro, Olympus Medical Systems Corporation (2010) Summary page 1.

## Most influential descendants
- K190969: ENDOSCOPE REPROCESSOR OER-Elite (2019), 1 descendant of its own
- K201920: Endoscope Reprocessor OER-Elite (2020), 0 descendants of its own
- K181472: AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor (2019), 0 descendants of its own
- K120357: Endoscope Reprocessor Oer-Mini (2012), 0 descendants of its own

## Recalls of this device
- Feb 12, 2026 · Class II · Z-1613-2026: 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: 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: 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 in
- Jul 12, 2023 · Class II · Z-2447-2023: 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 machin
- May 26, 2023 · Class II · Z-2342-2023: 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: 
- Jun 23, 2016 · Class II · Z-0138-2017: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K103264
Methodology: https://510kreport.com/methodology