# K163614: PENTAX Medical ED34-i10T, Video Duodenoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical
- Decided: Sep 20, 2017 after 272 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: 3 generations back to K832006 (1983). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 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
- 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

## Indications for use
The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

Source page: https://510kreport.com/device/K163614
Methodology: https://510kreport.com/methodology