# K201920: Endoscope Reprocessor OER-Elite

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 1, 2020 after 53 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914145 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190969: ENDOSCOPE REPROCESSOR OER-Elite, Olympus Medical Systems Corp. (2019) Summary page 5.

## Recalls of this device
- Mar 25, 2026 · Class II · Z-1903-2026: XXX
- Mar 25, 2026 · Class II · Z-1905-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1906-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1902-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1904-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1900-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1898-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1908-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1899-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1901-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1909-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Mar 25, 2026 · Class II · Z-1907-2026: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Feb 12, 2026 · Class II · Z-1612-2026: 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-0872-2026: 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: 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: 
- Dec 13, 2021 · Class II · Z-0638-2022: 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 cycl

## Indications for use
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.

Source page: https://510kreport.com/device/K201920
Methodology: https://510kreport.com/methodology