# K252586: Caddie

- Pathway: 510(k) (Special)
- Applicant: Odin Medical Limited
- Decided: Sep 12, 2025 after 28 days
- Product code: QNP (Gastrointesinal Lesion Software Detection System)
- Device class: 2
- Regulation: 21 CFR 876.1520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN200055 (2021). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240044: Caddie, Odin Medical Limited (2024) Summary page 5.

## Most influential descendants
- K260133: Caddie (2026), 0 descendants of its own

## Indications for use
The CADDIE computer-assisted detection device is intended to assist the gastroenterologist in detecting suspected colorectal polyps only. The gastroenterologist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. CADDIE is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. The CADDIE computer-assisted detection device is limited for use with standard white-light endoscopy imaging only.

Source page: https://510kreport.com/device/K252586
Methodology: https://510kreport.com/methodology