# Aeye Health, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 2 (2022–2024): 2 510(k) clearances
- Product codes: PIB (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Idx, LLC: 1 (https://510kreport.com/company/idx)

## Its most-cited devices
- K221183: Aeye-DS (2022), cited by 1

## Recent decisions
- K240058: Aeye-DS (Apr 23, 2024)
- K221183: Aeye-DS (Nov 10, 2022)

Source page: https://510kreport.com/company/aeye-health