# K181745: FUJIFILM Duodenoscope Model

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Mar 28, 2019 after 269 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- 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: 3 generations back to K944759 (1995). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152257: Fujifilm Duodenoscope Model ED-530XT, Fujifilm Medical Systems U.S.A, Inc. (2017) Summary page 4.

## Most influential descendants
- K191747: FUJIFILM Duodenoscope Model ED-580XT (2019), 2 descendants of its own
- K251861: FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 (2026), 0 descendants of its own
- K203028: FUJIFILM Distal End Cap (2020), 0 descendants of its own

## Indications for use
This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Source page: https://510kreport.com/device/K181745
Methodology: https://510kreport.com/methodology