# K231249: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Jul 28, 2023 after 88 days
- Product code: PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150618: PENTAX Medical EPK-i7010 Video Processor with GI Family, Pentax of America, Inc. (2015) Summary page 6.
- K131902: Pentax Video Upper G.I. Scopes (EG Family), Pentax Medical Company (2014) Summary page 6.
- K131855: Pentax Video Colonoscopes (EC Family), Pentax Medical Company (2014) Summary page 6.

## Most influential descendants
- K251127: PENTAX Medical Video Processor (EPK-i8020c) (2025), 0 descendants of its own

## Recalls of this device
- Jul 16, 2025 · Class II · Z-2329-2025: During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam 
- Jan 29, 2025 · Class II · Z-1238-2025: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-
- Jan 29, 2025 · Class II · Z-1237-2025: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-
- Jan 29, 2025 · Class II · Z-1236-2025: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-

## Indications for use
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes. The PENTAX Medical Video Upper GI Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes 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 20 kg of body weight. The PENTAX Medical Video Colonoscope EC38-i20cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes 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 20 kg of body weight.

Source page: https://510kreport.com/device/K231249
Methodology: https://510kreport.com/methodology