510(k) Report

FDA applicant

Aeye Health, Inc.

New York, NY2 decisions2022–20240 recalls

FDA records 2 decisions for Aeye Health, Inc. (New York, NY) from 2022 to 2024: 2 510(k) clearances. All are in product code PIB (Diabetic Retinopathy Detection Device). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Aeye Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Aeye Health, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aeye Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PIBDiabetic Retinopathy Detection Device2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221183Aeye-DSAeye Health, Inc. · 20221cites it

What has FDA decided for it lately?

  • K240058Aeye-DSAeye Health, Inc. · 2024
  • K221183Aeye-DSAeye Health, Inc. · 2022

All 2 as Aeye Health, Inc. →