# K210851: DiLumen Endolumenal Interventional Platform (DiLumen)

- Pathway: 510(k) (Special)
- Applicant: Lumendi, LLC
- Decided: Apr 21, 2021 after 30 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: 5 generations back to K040836 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182540: DiLumen Endolumenal Interventional Platform, Lumendi, LLC (2018) Summary page 4.

## Indications for use
The Lumendi DiLumen is an accessory to an endoscope. The DilLumen 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/K210851
Methodology: https://510kreport.com/methodology