# K210710: PENTAX Medical Video Duedenoscope ED34-i10T2

- Pathway: 510(k) (Special)
- Applicant: Pentax of America, Inc.
- Decided: Apr 9, 2021 after 30 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: 6 generations back to K832006 (1983). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192245: Pentax Medical Video Duodenoscope ED34-i10T2, Pentax of America, Inc. (2019) Summary page 4.

## Recalls of this device
- Apr 21, 2021 · Class II · Z-1682-2021: IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) une

## Indications for use
The PENTAX Medical Video Duodenoscope ED34-ilOT2 is intended to be used with endoscopic devices and other ancillary equipment 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. This endoscope is 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/K210710
Methodology: https://510kreport.com/methodology