# K161222: PENTAX MEDICAL ED-3490TK, Video Duodenoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical
- Decided: Feb 7, 2018 after 649 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K832006 (1983). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092710: Pentax ED-3490TK, Video Duodenoscope, Pentax Medical Company (2009) Summary page 4.

## Most influential descendants
- K181522: PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope (2018), 5 descendants of its own
- K192245: Pentax Medical Video Duodenoscope ED34-i10T2 (2019), 3 descendants of its own
- K233942: PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) (2024), 0 descendants of its own
- K210710: PENTAX Medical Video Duedenoscope ED34-i10T2 (2021), 0 descendants of its own
- K202365: Pentax Medical Video Duodenoscope ED32-i10 (2021), 0 descendants of its own

## Recalls of this device
- Feb 13, 2018 · Class II · Z-0643-2018: The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated

## Indications for use
The 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/K161222
Methodology: https://510kreport.com/methodology