# K042076: Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Nov 18, 2004 after 108 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: 1 generation back to K944759 (1995). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944620: Series 400 Gastroenterology System, Marks & Murase (1995) Summary page 1.
- K944759: 200 Series Gastro-Intestinal Video System, Fujinon, Inc. (1995) Summary page 1.

## Most influential descendants
- K152257: Fujifilm Duodenoscope Model ED-530XT (2017), 5 descendants of its own
- K181745: FUJIFILM Duodenoscope Model (2019), 3 descendants of its own
- 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

## Recalls of this device
- Dec 23, 2015 · Class II · Z-1864-2016: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Dec 23, 2015 · Class II · Z-1863-2016: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Dec 23, 2015 · Class II · Z-1860-2016: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Jun 30, 2015 · Class II · Z-2778-2015: The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

## Indications for use
The 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/K042076
Methodology: https://510kreport.com/methodology