510(k) Report

FDA applicant

Eyenuk, Inc.

Los Angeles, CA2 decisions2020–20230 recalls

FDA records 2 decisions for Eyenuk, Inc. (Los Angeles, CA) from 2020 to 2023: 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 Eyenuk, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12023: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Eyenuk, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eyenuk, 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.

  • K200667EyeArtEyenuk, Inc. · 20201cites it

What has FDA decided for it lately?

  • K223357EyeArt v2.2.0Eyenuk, Inc. · 2023
  • K200667EyeArtEyenuk, Inc. · 2020

All 2 as Eyenuk, Inc. →