# K152257: Fujifilm Duodenoscope Model ED-530XT

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jul 21, 2017 after 711 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944759 (1995). 3 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K042076: Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5, Fujinon, Inc. (2004) Summary page 4.

## Most influential descendants
- 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
- K182051: FUJIFILM Duodenoscope Model (2018), 0 descendants of its own

## Recalls of this device
- Jul 21, 2017 · Class II · Z-3225-2017: An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanis
- Mar 9, 2015 · Class II · Z-3128-2017: Fujifilm is reporting a corrective action due to an FDA inspection.
- Mar 9, 2015 · Class II · Z-3129-2017: Fujifilm is conducting a corrective action due to an FDA inspection.

## Indications for use
The Fujifilm Duodenoscope Model 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/K152257
Methodology: https://510kreport.com/methodology