# K182051: FUJIFILM Duodenoscope Model

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Oct 2, 2018 after 63 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
ED-530XT 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/K182051
Methodology: https://510kreport.com/methodology