# K182540: DiLumen Endolumenal Interventional Platform

- Pathway: 510(k) (Traditional)
- Applicant: Lumendi, LLC
- Decided: Oct 30, 2018 after 46 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: 4 generations back to K040836 (2004). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173400: ORISE Tissue Retractor System, Boston Scientific (2018) Summary page 4.

## Most influential descendants
- K210851: DiLumen Endolumenal Interventional Platform (DiLumen) (2021), 0 descendants of its own

## Indications for use
The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.

Source page: https://510kreport.com/device/K182540
Methodology: https://510kreport.com/methodology