510(k) · Cleared
ClearedEyeArt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eyenuk, Inc. · PIB Diabetic Retinopathy Detection Device
Cleared on Aug 3, 2020 as substantially equivalent to DEN180001 (Idx, LLC, 2018) after a 143-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Aug 3, 2020
- Review
- 143 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- K223357EyeArt v2.2.0Eyenuk, Inc. · 2023 · 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) | K200667 | EyeArt | Eyenuk, Inc. | 2020 | — |
| +1 | K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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…ss II Regulation: 21 CFR 886.1100 Product Code: PIB Legally Marketed Predicate Device Trade name of the device: IDx-DR Manufacturer’s Name: IDx LLC De Novo Number: DEN180001 A. Intended Use / Indications for Use EyeArt is indicated for use by healthcare providers to automatically detect more… | 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 |
|---|---|---|---|
| K223357 | EyeArt v2.2.0 | 2023 | 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. 2020, 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?
EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy (severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and/or diabetic macular edema) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with more than mild diabetic retinopathy. EyeArt is indicated for use with Canon CR-2 AF and Canon CR-2 Plus AF cameras in both primary care and eye care settings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200667: EyeArt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200667
Report an extraction error
Are you the manufacturer?
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