Skip to content

Endoscope Reprocessor Oer-Mini

by Olympus Medical Systems Corporation

Endoscope Reprocessor Oer-Mini is an instrument non-thermal chemical disinfector (FDA Class II; FDA product code FEB, Accessories, Cleaning, For Endoscope) made by Olympus Medical Systems Corporation, cleared under FDA 510(k) K120357 on 20 Dec 2012 and listed in FDA GUDID since 18 Dec 2021 (UDI-DI 04953170331619), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K120357

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170331619 UDI-DI Date18 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120357 Date20 Dec 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120357 decided 20 Dec 2012 Active
  • FDA GUDID UDI-DI 04953170331619 listed 18 Dec 2021 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0874-2026 FDA Class II initiated 31 Oct 2025

    Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

    • Ongoing Z-2343-2023 FDA Class II initiated 26 May 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: 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

Timeline

4 dated events

  1. Cleared FDA 510(k) K120357
  2. Listed FDA GUDID 04953170331619
  3. Recall initiated FDA recalls Z-2343-2023
  4. Recall initiated FDA recalls Z-0874-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Endoscope Reprocessor
Generic name
Instrument non-thermal chemical disinfector
Model / reference
OER-MINI
Primary DI / UDI-DI
04953170331619
510(k) Number
FDA product code
FEB
GMDN term
Instrument non-thermal chemical disinfector
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope washer-disinfector (chemical)

Cleared under the same submission (K120357)

and 8 more cleared under K120357

Similar devices

Other devices filed under FDA product code FEB (Accessories, Cleaning, For Endoscope).

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)