Heidelberg Engineering GmbH: FDA clearances and approvals
Heidelberg Engineering GmbH has 27 FDA 510(k) clearances (first 1991, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 91 days. Since 2017 its median was 157 days, against 157 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named Heidelberg Engineering GmbH. It is the industry lead sponsor of 14 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 111 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 274 |
| 2017 | 1 | 57 |
| 2018 | 3 | 87 |
| 2019 | 1 | 23 |
| 2020 | 1 | 121 |
| 2021 | 1 | 147 |
| 2022 | 0 | — |
| 2023 | 2 | 262 |
| 2024 | 3 | 168 |
| 2025 | 1 | 49 |
| 2026 | 2 | 162 |
Review time against the same product codes
Since 2017, Heidelberg Engineering GmbH's cleared 510(k)s took a median 157 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | 20 | 20 |
| HLI | Ophthalmoscope, Ac-Powered | 5 | 5 |
| MXK | Device, Analysis, Anterior Segment | 2 | 2 |
Review panels
- Ophthalmic (27)
Most recent Heidelberg Engineering GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261019 | ANTERION | OBO | 2026-09-11 | 168 |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | OBO | 2026-05-07 | 157 |
| K250868 | SPECTRALIS HRA+OCT and variants | OBO | 2025-05-12 | 49 |
| K240924 | Anterion | OBO | 2024-12-13 | 253 |
| K241163 | SPECTRALIS with Flex Module | OBO | 2024-10-11 | 168 |
| K240221 | SPECTRALIS HRA+OCT and variants | OBO | 2024-07-01 | 157 |
| K223557 | SPECTRALIS HRA+OCT and variants | OBO | 2023-10-20 | 329 |
| K230897 | Anterion | OBO | 2023-10-11 | 194 |
| K211817 | Anterion | OBO | 2021-11-05 | 147 |
| K201252 | Spectralis HRA+OCT and variants | OBO | 2020-09-09 | 121 |
17 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2026-08-06.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Heidelberg Engineering GmbH is the industry lead sponsor of 14 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06657716: Heidelberg Engineering ANTERION Software Comparison Study (Active not recruiting, started 2024-10-02)
- NCT05051813: The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study (Completed, started 2021-09-07)
- NCT04961398: Evaluation of Heidelberg Engineering SPECTRALIS OCT Signal to Noise Ratio Effect on Parameter Measurements (Completed, started 2021-06-21)
- NCT04661124: Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position (Completed, started 2020-12-10)
- NCT04604002: Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types (Completed, started 2020-10-15)
Frequently asked questions
How many FDA 510(k) clearances does Heidelberg Engineering GmbH have?
Heidelberg Engineering GmbH has 27 FDA 510(k) clearances (first 1991, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear Heidelberg Engineering GmbH's 510(k)s?
The median time from FDA receipt to decision across Heidelberg Engineering GmbH's cleared 510(k)s is 91 days. Since 2017: 157 days, versus 157 days for all cleared 510(k)s in the same product codes.
What devices does Heidelberg Engineering GmbH make?
Its most frequent FDA product codes are OBO (Tomography, Optical Coherence, 20); HLI (Ophthalmoscope, Ac-Powered, 5); MXK (Device, Analysis, Anterior Segment, 2).
Has Heidelberg Engineering GmbH had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Heidelberg Engineering GmbH; the most recent began 2026-08-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 27 Heidelberg Engineering GmbH clearances with predicates and recalls
- Run predicate analysis for product code OBO, Heidelberg Engineering GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.