510(k) · Cleared
ClearedAnterion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heidelberg Engineering GmbH · OBO Tomography, Optical Coherence
Cleared on Sep 11, 2026 as substantially equivalent to K240924 (Heidelberg Engineering GmbH, 2024) after a 168-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Sep 11, 2026
- Review
- 168 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051789 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK051789 Visante OctCarl Zeiss Meditec, Inc. · 2005
- 3 generations backK211817 AnterionHeidelberg Engineering GmbH · 2021
- 2 generations backK230897 AnterionHeidelberg Engineering GmbH · 2023
- 1 generation backK240924 AnterionHeidelberg Engineering GmbH · 2024
- This deviceK261019 AnterionHeidelberg Engineering GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051789 | Visante Oct | Carl Zeiss Meditec, Inc. | 2005 | — |
| −3 | K211817 | Anterion | Heidelberg Engineering GmbH | 2021 | — |
| −2 | K230897 | Anterion | Heidelberg Engineering GmbH | 2023 | — |
| −1 | K240924 | Anterion | Heidelberg Engineering GmbH | 2024 | — |
| 0 (this device) | K261019 | Anterion | Heidelberg Engineering GmbH | 2026 | — |
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 OBO? 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 OBO device
- #1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 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 |
|---|---|---|---|
| * | K240924 | AnterionSummary page 5…II Classification Panel: Ophthalmic Device Panel Product Code: OBO PREDICATE DEVICE ANTERION (K240924), Heidelberg Engineering GmbH Heidelberg Engineering GmbH Traditional 510(k): ANTERION K261019… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OBO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBO
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBO
4in 2025
MAUDE reports naming product code OBO, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 4 | 151 | 0 | 0 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 2 | — | 2 | 0 |
| 2012 | 3 | 269 | 2 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 152 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 4 | 125 | 0 | 1 |
| 2017 | 4 | 118 | 0 | 0 |
| 2018 | 6 | 87 | 1 | 1 |
| 2019 | 5 | 249 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 1 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 7 | 262 | 0 | 3 |
| 2024 | 8 | 157 | 0 | 3 |
| 2025 | 3 | 125 | 0 | 4 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and the measurement of the axial length.
The analysis covers:
• Cornea Thickness
• Anterior Segment
o Anterior chamber width, depth, volume and angle parameters
o Lens Thickness
• Axial Length
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/K261019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261019: Anterion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261019
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026