# K192280: PENTAX Medical ED-3490TK Video Duodenoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical
- Decided: Oct 21, 2019 after 60 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 K832006 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181522: PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope, Pentax of America, Inc. (2018) Summary page 4.

## Indications for use
The PENTAX Medical ED-3490TK Video Duodenoscope is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

Source page: https://510kreport.com/device/K192280
Methodology: https://510kreport.com/methodology