Endoscope Reprocessor Oer-Mini

• • 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

1. 20 Dec 2012 Cleared FDA 510(k) K120357
2. 26 May 2023 Recall initiated FDA recalls Z-2343-2023
3. 31 Oct 2025 Recall initiated FDA recalls Z-0874-2026

510(k) Number

K120357 ↗

FDA product code

FEB

Device class

Class II

Regulation

21 CFR Part 876.1500

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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

• EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT by H & C Chemical, Inc.
• VIRAPUMP II (MODELS AND MODEL M) by Viatro, Corp.
• BLUE PLANET LENS FOG REDUCTION & CLEANING KIT by Blue Planet Industries, Inc.
• Advantage Plus Pass-Thru by MEDIVATORS INC.
• FLEXIBLE URETERONEPHROSOCOPE by APPLIED MEDICAL RESOURCES CORP.
• enspire 3000 Cleaning and Liquid Chemical Sterile Processing System by STERIS CORPORATION
• SPARCO SCOPE GUARD by Sparco, Inc.
• SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR by Custom Ultrasonics, Inc.
• KEY-MED FIBRESCOPE DISINFECTION TROLLEY by Keymed, Inc.
• PSK ENDOSCOPE CLEANING SYSTEM by Psk Connectors Pty, Ltd.

• POWER CORD KR 4.5m MAJ-2398

  Class I

  CE/MDR

• Power Cord Dk Maj-2282

  Class I

  CE/MDR

• POWER CORD KR 4.5m MAJ-2396

  Class I

  CE/MDR

• Hdtv Monitor Remote / Communication Cable for Ucr 2.5M Maj-2047

  Class I

  CE/MDR

See all devices from Olympus Medical Systems Corporation →