FDA product code OBO: Tomography, Optical Coherence
OBO is the FDA product code for tomography, optical coherence. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel. FDA has cleared 67 510(k) submissions under OBO, 22 in the last five years, from 19 different applicants. The average 510(k) review took 173 days (median 156); 144 days on average over the last three years. FDA has posted 12 recalls for OBO devices, 3 initiated in the last five years.
Definition
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Classification
| Field | Value |
|---|---|
| Device name | Tomography, Optical Coherence |
| Device class | Class II |
| Regulation | 21 CFR 886.1570 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for OBO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 124 |
| 2018 | 6 | 113 |
| 2019 | 5 | 206 |
| 2020 | 2 | 152 |
| 2021 | 1 | 147 |
| 2022 | 2 | 160 |
| 2023 | 7 | 261 |
| 2024 | 8 | 164 |
| 2025 | 3 | 106 |
| 2026 | 2 | 162 |
Compare with all 510(k) review times · Search every OBO clearance
Top OBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Heidelberg Engineering GmbH | 18 | 2026-09-11 |
| Carl Zeiss Meditec, Inc. | 8 | 2024-05-17 |
| Optovue, Inc. | 7 | 2022-11-09 |
| Topcon Corporation | 6 | 2024-07-17 |
| Optos Plc. | 5 | 2024-05-09 |
14 more applicants have OBO clearances. See the full list in Caduvo.
Most recent OBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261019 | Heidelberg Engineering GmbH | ANTERION | 2026-09-11 | 168 |
| K253837 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | 2026-05-07 | 157 |
| K252633 | Cylite Pty. , Ltd. | UNITY DX (UDX) | 2025-12-23 | 125 |
| K250553 | Tomey Corporation | Tomey Cornea/Anterior Segment OCT (CASIA2) | 2025-07-18 | 143 |
| K250868 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants | 2025-05-12 | 49 |
Recalls for OBO devices
12 product recalls in 11 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2026-08-06.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code OBO?
OBO is the FDA product code for tomography, optical coherence. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel.
What device class is OBO?
Class II, regulation 21 CFR 886.1570. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBO?
Across 67 cleared submissions the average was 173 days from receipt to decision (median 156).
Which companies have the most OBO clearances?
Heidelberg Engineering GmbH (18); Carl Zeiss Meditec, Inc. (8); Optovue, Inc. (7); Topcon Corporation (6); Optos Plc. (5).
Have OBO devices been recalled?
Yes: 12 product recalls across 11 recall events; the most recent began 2026-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code OBO
- Run a recall and safety report across every OBO manufacturer
- Watch product code OBO 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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