# K102466: Fujinon Epx-4440HD Digital Video Processor

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: May 25, 2011 after 268 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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: 1 generation back to K944620 (1995). 1 ancestor in all.
37 later devices descend from it; 4 cite it directly.
0 of 39 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.

## Most influential descendants
- K140149: Epx-4440HD Digital Video Processor (2014), 16 descendants of its own
- K163675: Processor VP-7000, Light Source BL-7000 (2017), 12 descendants of its own
- K131953: IMAGE1 Spies (2013), 10 descendants of its own
- K162836: FUJIFILM Surgical System (2017), 8 descendants of its own
- K113873: Pentax Epk-I5020 Video Processor (2012), 7 descendants of its own

## Indications for use
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices. The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.

Source page: https://510kreport.com/device/K102466
Methodology: https://510kreport.com/methodology