FDA product code PIB: Diabetic Retinopathy Detection Device
PIB is the FDA product code for diabetic retinopathy detection device. It is a Class II device, regulated under 21 CFR 886.1100 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under PIB, 5 in the last five years, from 4 different applicants. The average 510(k) review took 192 days (median 199); 163 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.
Classification
| Field | Value |
|---|---|
| Device name | Diabetic Retinopathy Detection Device |
| Device class | Class II |
| Regulation | 21 CFR 886.1100 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for PIB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 143 |
| 2021 | 1 | 181 |
| 2022 | 2 | 234 |
| 2023 | 1 | 226 |
| 2024 | 1 | 106 |
| 2026 | 1 | 220 |
Compare with all 510(k) review times · Search every PIB clearance
Top PIB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aeye Health, Inc. | 2 | 2024-04-23 |
| Eyenuk, Inc. | 2 | 2023-06-16 |
| Digital Diagnostics, Inc. | 2 | 2022-06-17 |
| iHealthscreen, Inc. | 1 | 2026-07-02 |
Most recent PIB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253704 | iHealthscreen, Inc. | iPredict-DR | 2026-07-02 | 220 |
| K240058 | Aeye Health, Inc. | AEYE-DS | 2024-04-23 | 106 |
| K223357 | Eyenuk, Inc. | EyeArt v2.2.0 | 2023-06-16 | 226 |
| K221183 | Aeye Health, Inc. | AEYE-DS | 2022-11-10 | 199 |
| K213037 | Digital Diagnostics, Inc. | IDx-DR v2.3 | 2022-06-17 | 269 |
Recalls for PIB devices
openFDA lists no recalls for product code PIB.
Frequently asked questions
What is FDA product code PIB?
PIB is the FDA product code for diabetic retinopathy detection device. It is a Class II device, regulated under 21 CFR 886.1100 and reviewed by the Ophthalmic panel.
What device class is PIB?
Class II, regulation 21 CFR 886.1100. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIB?
Across 7 cleared submissions the average was 192 days from receipt to decision (median 199).
Which companies have the most PIB clearances?
Aeye Health, Inc. (2); Eyenuk, Inc. (2); Digital Diagnostics, Inc. (2); iHealthscreen, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PIB
- Run a recall and safety report across every PIB manufacturer
- Watch product code PIB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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