# K251867: Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 19, 2025 after 94 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K080403 (2008). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250701: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V), Olympus Medical Systems Corp. (2025) Summary page 5.

## Recalls of this device
- Oct 14, 2025 · Class II · Z-0579-2026: Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing user

## Indications for use
The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Source page: https://510kreport.com/device/K251867
Methodology: https://510kreport.com/methodology