# K190805: PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Dec 20, 2019 after 266 days
- Product code: PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement)
- 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: 10 generations back to K931154 (1993). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122470: Pentax Epk-I5010 Video Processor, Pentax Medical (2013) Summary page 8.
- K131902: Pentax Video Upper G.I. Scopes (EG Family), Pentax Medical Company (2014) Summary page 8.
- K131855: Pentax Video Colonoscopes (EC Family), Pentax Medical Company (2014) Summary page 8.

## Most influential descendants
- K232249: PENTAX Medical Gas/Water Feeding Valve OE-B14 (2023), 0 descendants of its own

## Indications for use
The PENTAX Medical Video Colonoscope EC34-i10cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight. The PENTAX Medical Video Colonoscope EC38-i10cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight. The PENTAX Medical Video Upper GI Scope EG29-i10c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight. The PENTAX Medical Video Processor EPK-i5500c is intended to be used with the PENTAX Medical camera heads, endoscopes, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. It processes signals transmitted from a video endoscope into images that are displayed on an inspection monitor. This processor has air/water pump function. This device includes PENTAX i-scan™, a digital, post-processing imaging enhancement technology. i-scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.

Source page: https://510kreport.com/device/K190805
Methodology: https://510kreport.com/methodology