# K251861: FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Mar 9, 2026 after 265 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: 10 generations back to K931154 (1993). 41 ancestors in all.
No later device cites it as a predicate yet.
3 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980465: Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus Maj-311/Maj-411 Distal Covers, Olympus America, Inc. (1998) Summary page 5.
- K191747: FUJIFILM Duodenoscope Model ED-580XT, Fujifilm Corporation (2019) Summary page 5.
- K233886: Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2, Ambu A/S (2024) Summary page 5.
- K072957: Evis Exera II 180 System, Olympus Medical Systems Corporation (2008) Summary page 5.

## Indications for use
a) ED-S100TP, ED-S100XP This product has been designed for endoscopy and endoscopic surgery within the duodenum. b) VS-1000 This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope.

Source page: https://510kreport.com/device/K251861
Methodology: https://510kreport.com/methodology