# K221452: DiLumen C1, EZ1 and Tool Mount

- Pathway: 510(k) (Traditional)
- Applicant: Lumendi, LLC
- Decided: Feb 10, 2023 after 268 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: 6 generations back to K993704 (2000). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211819: DiLumen C2 and Tool Mount, Lumendi, LLC (2021) Summary page 4.

## Most influential descendants
- K231323: Ancora-SB (2023), 1 descendant of its own
- K260314: Ancora-SB (2026), 0 descendants of its own

## Indications for use
The Lumendi DiLumen C1 and EZ1 is an endoscope accessory intended 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/K221452
Methodology: https://510kreport.com/methodology