# K944620: Series 400 Gastroenterology System

- Pathway: 510(k) (Traditional)
- Applicant: Marks & Murase
- Decided: Apr 27, 1995 after 219 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
125 later devices descend from it; 5 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K041903: Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 (2004), 75 descendants of its own
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (2009), 45 descendants of its own
- K042043: Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 (2004), 39 descendants of its own
- K102466: Fujinon Epx-4440HD Digital Video Processor (2011), 37 descendants of its own
- K112391: Fujinon Colonoscopes (2012), 33 descendants of its own

## Recalls of this device
- 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.
- Mar 27, 2006 · Not classified · Z-0708-06: Colonoscope insertion tube is not bending properly and is stiff.

Source page: https://510kreport.com/device/K944620
Methodology: https://510kreport.com/methodology