# K954451: Evis 140 System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Mar 29, 1996 after 186 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853585 (1986). 2 ancestors in all.
318 later devices descend from it; 10 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)
- K853585: Olympus Evs-Endoscopic Video Image & Data Sys, Olympus Corp. (1986) Summary page 1.
- K931154: Evis 200 System, Olympus Corp. (1993) Summary page 1.

## Most influential descendants
- 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
- K971660: Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment (1997), 75 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0329-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Sep 25, 2023 · Class II · Z-0334-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Sep 25, 2023 · Class II · Z-0346-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten

## Indications for use
The EVIS 140 System is specifically designed for endoscopic diagnosis, treatment, and photo and video documentation in combination with Olympus endoscopes, various accessories and ancillary equipment within the upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliaty duct, duodenum, small intestine, rectum and colon. The intended use of EVIS 140 System and associated endoscopes are identical to the currently marketed EVS System which was cleared for marketing in the 510(k) # K853585. Both systems are used for observation, photo and video documentation of the images within the upper and lower GI tract. Thus, when compared to the predicate device, Olympus EVIS 140 System does not raise any questions regarding the safety of the subject device.

Source page: https://510kreport.com/device/K954451
Methodology: https://510kreport.com/methodology