# K092710: Pentax ED-3490TK, Video Duodenoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: Dec 2, 2009 after 90 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K832006 (1983). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963056: ED-3410, Video Duodenoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- (no number) EPK-i, Video Processor: named in the summary without a submission number

## Most influential descendants
- K161222: PENTAX MEDICAL ED-3490TK, Video Duodenoscope (2018), 6 descendants of its own
- K181522: PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope (2018), 5 descendants of its own
- K163614: PENTAX Medical ED34-i10T, Video Duodenoscope (2017), 4 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

## 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
- Jan 17, 2017 · Class II · Z-2713-2017: Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap

## 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: Esophogus, 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 inacdult and pediatric popuiations.

Source page: https://510kreport.com/device/K092710
Methodology: https://510kreport.com/methodology