# K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Jul 2, 2026 after 27 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: 12 generations back to K931154 (1993). 56 ancestors in all.
No later device cites it as a predicate yet.
3 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243260: FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R, Fujifilm Corporation (2025) Summary page 5.
- K153483: Balloon controller PB-30, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 5.
- K223827: FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01, Fujifilm Corporation (2023) Summary page 5.

## Indications for use
Processor EP-8000 The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment. BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis. PB-30 This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over-tube insertion. This product is not intended for use for any neonates, infants or children. EW10-VM01 This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.

Source page: https://510kreport.com/device/K261880
Methodology: https://510kreport.com/methodology