# K242110: PENTAX Medical Video Colonoscope (EC38-i20cWL)

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Jan 3, 2025 after 168 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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: 9 generations back to K931154 (1993). 29 ancestors in all.
No later device cites it as a predicate yet.
3 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131855: Pentax Video Colonoscopes (EC Family), Pentax Medical Company (2014) Summary page 6.

## Indications for use
The PENTAX Medical Video Colonoscope EC38-i20cWL 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 20kg of body weight.

Source page: https://510kreport.com/device/K242110
Methodology: https://510kreport.com/methodology