De Novo · Granted
GrantedIDx-DR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Idx, LLC · PIB Diabetic Retinopathy Detection Device
Granted on Apr 11, 2018 as a new device type through De Novo after an 89-day review. 7 later devices descend from it.
- Decided
- Apr 11, 2018
- Review
- 89 days
- Class
- Class II
- Product code
- PIB
- Recalls
- None
7 later devices descend from it, 3 citing it directly.
- This deviceDEN180001 IDx-DRIdx, LLC · 2018
- Descendant · cites it directly · 2 of its ownK203629 IDx-DRDigital Diagnostics, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK221183 Aeye-DSAeye Health, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK200667 EyeArtEyenuk, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK253704 iPredict-DRiHealthscreen, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240058 Aeye-DSAeye Health, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K203629IDx-DRDigital Diagnostics, Inc. · 2021 · cites it directly2descendants
- K221183Aeye-DSAeye Health, Inc. · 2022 · cites it directly1descendant
- K200667EyeArtEyenuk, Inc. · 2020 · cites it directly1descendant
- K253704iPredict-DRiHealthscreen, Inc. · 2026 · 2 generations on0descendants
- K240058Aeye-DSAeye Health, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180001 | IDx-DR | Idx, LLC | 2018 | — |
| +1 | K203629 | IDx-DR | Digital Diagnostics, Inc. | 2021 | — |
| +1 | K221183 | Aeye-DS | Aeye Health, Inc. | 2022 | — |
| +1 | K200667 | EyeArt | Eyenuk, Inc. | 2020 | — |
| +2 | K253704 | iPredict-DR | iHealthscreen, Inc. | 2026 | — |
| +2 | K240058 | Aeye-DS | Aeye Health, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K203629 (Digital Diagnostics, Inc., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All PIB devicesPIB Diabetic Retinopathy Detection Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
IDx-DR 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. IDx-DR is indicated for use with the Topcon NW400.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180001 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN180001: IDx-DR.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN180001
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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