# K203028: FUJIFILM Distal End Cap

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Oct 30, 2020 after 28 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: 5 generations back to K944759 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191747: FUJIFILM Duodenoscope Model ED-580XT, Fujifilm Corporation (2019) Summary page 4.

## Indications for use
This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures. Do not use this product for any other purposes.

Source page: https://510kreport.com/device/K203028
Methodology: https://510kreport.com/methodology