# Endoscope Reprocessor Oer-Mini

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/endoscope-reprocessor-oer-mini-feb>
- Manufacturer: [Olympus Medical Systems Corp.](https://devicerts.com/manufacturers/olympus-medical-systems-corporation) (FDA registration: Japan)
- Name in the registry: ENDOSCOPE REPROCESSOR OER-MINI
- Device class: Class II (US FDA)
- FDA product code: FEB

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K120357 · decision 2012-12-20 · decision SESE · status: Active

## Recalls

- Z-0874-2026 · Class II · ongoing · initiated 2025-10-31: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Z-2343-2023 · Class II · ongoing · initiated 2023-05-26: 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 compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

## Identifiers

- 510(k) Number: K120357 [FDA 510(k)]
- FDA product code: FEB [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 876.1500 [FDA 510(k)]
- Advisory committee: Gastroenterology, Urology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Endoscope Reprocessor Oer-Mini, Olympus Medical Systems Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/endoscope-reprocessor-oer-mini-feb (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/endoscope-reprocessor-oer-mini-feb.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/endoscope-reprocessor-oer-mini-feb
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.