# K221183: Aeye-DS

- Pathway: 510(k) (Traditional)
- Applicant: Aeye Health, Inc.
- Decided: Nov 10, 2022 after 199 days
- Product code: PIB (Diabetic Retinopathy Detection Device)
- Device class: 2
- Regulation: 21 CFR 886.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180001 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180001: IDx-DR, Idx, LLC (2018) Summary page 4.

## Most influential descendants
- K240058: Aeye-DS (2024), 0 descendants of its own

## Indications for use
The AEYE-DS device is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. The AEYE-DS is indicated for use with the Topcon NW400.

Source page: https://510kreport.com/device/K221183
Methodology: https://510kreport.com/methodology