# K963056: ED-3410, Video Duodenoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Oct 10, 1996 after 65 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: 1 generation back to K832006 (1983). 3 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K832006: Pentax FD-34A Duodenofiberscope, Pentax Precision Instrument Corp. (1983) Summary page 1.
- K934920: VB-1830/VB-1530, Video Bronchoscope, Pentax Precision Instrument Corp. (1994) Summary page 1.
- K934918: Epm-3300 Video Processor, Pentax Precision Instrument Corp. (1994) Summary page 1.

## Most influential descendants
- K092710: Pentax ED-3490TK, Video Duodenoscope (2009), 8 descendants of its own
- 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

## Recalls of this device
- 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
- Apr 6, 2016 · Class II · Z-2277-2016: Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

## Indications for use
The ED-3410, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper Gastrointestinal Tract and Biliary Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

Source page: https://510kreport.com/device/K963056
Methodology: https://510kreport.com/methodology