510(k) · Cleared
ClearedIDx-DR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digital Diagnostics, Inc. · PIB Diabetic Retinopathy Detection Device
Cleared on Jun 10, 2021 as substantially equivalent to DEN180001 (Idx, LLC, 2018) after a 181-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Jun 10, 2021
- Review
- 181 days
- Class
- Class II
- Product code
- PIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180001 (2018). 2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView 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) | K203629 | IDx-DR | Digital Diagnostics, Inc. | 2021 | — |
| +1 | K253704 | iPredict-DR | iHealthscreen, Inc. | 2026 | — |
| +1 | K213037 | IDx-DR v2.3 | Digital Diagnostics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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…Class: II Regulation: 21 CFR 886.1100 Product Code: PIB III. Predicate Device IDx-DR, Diabetic Retinopathy Detection Device, DEN180001 This predicate has not been subject to a design-related recall. No reference devices were used in this s… | 2018 |
What descends from it? (2)
2 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?
How does its category compare?
All PIB devicesPIB Diabetic Retinopathy Detection Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 healthcare providers to automatically detect more than mild diabetic retinopathy 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203629: IDx-DR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203629
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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