# K190969: ENDOSCOPE REPROCESSOR OER-Elite

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jul 9, 2019 after 88 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914145 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103264: Endoscope Reprocessor Oer-Pro Model Oer-Pro, Olympus Medical Systems Corporation (2011) Summary page 4.

## Most influential descendants
- K201920: Endoscope Reprocessor OER-Elite (2020), 0 descendants of its own

## Recalls of this device
- 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/K190969
Methodology: https://510kreport.com/methodology