# K093106: Endoscope Reprocessor Oer-Pro

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Feb 12, 2010 after 134 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914145 (1994). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914145: DSD-91(TM) Disinfector for Flexible Endoscopes, Medivators, Inc. (1994) Summary page 1.

## Most influential descendants
- K103264: Endoscope Reprocessor Oer-Pro Model Oer-Pro (2011), 4 descendants of its own
- K190969: ENDOSCOPE REPROCESSOR OER-Elite (2019), 1 descendant of its own
- K201920: Endoscope Reprocessor OER-Elite (2020), 0 descendants of its own
- K181472: AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor (2019), 0 descendants of its own
- K120357: Endoscope Reprocessor Oer-Mini (2012), 0 descendants of its own

## Indications for use
The OER-Pro is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes 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-Pro and Olympus flexible endoscopes and their 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-Pro components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Pro enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Pro.

Source page: https://510kreport.com/device/K093106
Methodology: https://510kreport.com/methodology