# K120357: Endoscope Reprocessor Oer-Mini

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Dec 20, 2012 after 318 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (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.
No later device cites it as a predicate yet.
0 of 4 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 1.

## Recalls of this device
- Oct 31, 2025 · Class II · Z-0874-2026: 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-2343-2023: 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: 

## Indications for use
The OER-Mini is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources, 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-Mini and Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources, and their accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and may damage the OER-Mini components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Mini enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Mini.

Source page: https://510kreport.com/device/K120357
Methodology: https://510kreport.com/methodology