# K853585: Olympus Evs-Endoscopic Video Image & Data Sys

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Jan 21, 1986 after 148 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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
No predicates in its family tree.
320 later devices descend from it; 4 cite it directly.
6 of 321 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K954451: Evis 140 System (1996), 318 descendants of its own
- K051645: Evis Exera 160A System (2005), 208 descendants of its own
- K062049: Evis Exera II 180 System (2006), 158 descendants of its own
- K061313: Evis Exera 180 System (2006), 158 descendants of its own
- K100584: Evis Exeraii 180 System (2010), 132 descendants of its own

## Recalls of this device
- May 11, 2018 · Class II · Z-2270-2018: Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and m
- May 11, 2018 · Class II · Z-2269-2018: Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated

Source page: https://510kreport.com/device/K853585
Methodology: https://510kreport.com/methodology