510(k) · Cleared
ClearedAeye-DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aeye Health, Inc. · PIB Diabetic Retinopathy Detection Device
Cleared on Nov 10, 2022 as substantially equivalent to DEN180001 (Idx, LLC, 2018) after a 199-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Nov 10, 2022
- Review
- 199 days
- Class
- Class II
- Product code
- PIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180001 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K240058Aeye-DSAeye Health, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180001 | IDx-DR | Idx, LLC | 2018 | — |
| 0 (this device) | K221183 | Aeye-DS | Aeye Health, Inc. | 2022 | — |
| +1 | K240058 | Aeye-DS | Aeye Health, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PIB device
- #1 K253704 iPredict-DRscore 11.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180001 | IDx-DRSummary page 4…Predicate Device Manufacturer 510(k) No. Main IDx-DR IDx LLC DEN180001 Device Description: AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic image… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240058 | Aeye-DS | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PIB devicesPIB Diabetic Retinopathy Detection Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PIB
Too few PIB 510(k)s in any year since 2007 to give a median.
Recalls per year · PIB
No recall names PIB since 2007.
Adverse event reports per year · PIB
1in 2025
MAUDE reports naming product code PIB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221183 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221183: Aeye-DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221183
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026