# K220587: Evis Exera III Duodenovideoscope Olympus TJF-Q190V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: May 11, 2022 after 71 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K080403 (2008). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202661: Evis Exera III Duodenovideoscope Olympus TJF-Q190V, Olympus Medical Systems Corp. (2020) Summary page 5.

## Most influential descendants
- K253646: Single Use Distal Cover MAJ-2315 (MAJ-2315) (2026), 0 descendants of its own

## Recalls of this device
- Jun 5, 2026 · Class II · Z-2676-2026: Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- May 5, 2025 · Class II · Z-1911-2025: Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was 
- Dec 8, 2023 · Class II · Z-1071-2024: Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retaine
- Jul 27, 2023 · Class II · Z-2467-2023: Recent reports of patient infection.

## Indications for use
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Source page: https://510kreport.com/device/K220587
Methodology: https://510kreport.com/methodology