# K162428: DiLumen Endolumenal Interventional Platform

- Pathway: 510(k) (Traditional)
- Applicant: Lumendi, LLC
- Decided: Dec 6, 2016 after 98 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: 3 generations back to K993704 (2000). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15, Fujinon, Inc. (2009) Summary page 4.

## Most influential descendants
- K173317: DiLumen C2; DiLumen Tool Mount (2018), 4 descendants of its own
- K211819: DiLumen C2 and Tool Mount (2021), 3 descendants of its own
- K221452: DiLumen C1, EZ1 and Tool Mount (2023), 2 descendants of its own
- K231323: Ancora-SB (2023), 1 descendant of its own
- K213773: Insufflation Retention Device (2022), 1 descendant 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 and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

Source page: https://510kreport.com/device/K162428
Methodology: https://510kreport.com/methodology