# K253704: iPredict-DR

- Pathway: 510(k) (Traditional)
- Applicant: iHealthscreen, Inc.
- Decided: Jul 2, 2026 after 220 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: 2 generations back to DEN180001 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203629: IDx-DR, Digital Diagnostics, Inc. (2021) Summary page 5.

## Indications for use
iPredict-DR is intended for use by healthcare providers to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. iPredict-DR is indicated for use with iCare’s DRSPIlus color fundus camera.

Source page: https://510kreport.com/device/K253704
Methodology: https://510kreport.com/methodology