510(k) · Cleared
ClearedTomey Cornea/Anterior Segment OCT CASIA2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomey Corporation · OBO Tomography, Optical Coherence
Cleared on Apr 27, 2022 as substantially equivalent to K180660 (Optovue, Inc., 2018) after a 209-day review. Its family tree reaches back 9 generations to 2002. 1 later device descends from it.
- Decided
- Apr 27, 2022
- Review
- 209 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K012727 (2002). 16 ancestors in all, the oldest K955442 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 5 generations between
- 3 generations backK120238 Rtvue XR OctOptovue, Inc. · 2012
- 2 generations backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- 1 generation backK180660 AvantiOptovue, Inc. · 2018
- This deviceK213265 Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation · 2022
- Descendant · cites it directly · 0 of its ownK250553 Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation · 2025
Show all 9 generations
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 8 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 7 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 6 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 5 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 4 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 3 generations backK120238 Rtvue XR OctOptovue, Inc. · 2012
- 2 generations backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- 1 generation backK180660 AvantiOptovue, Inc. · 2018
- This deviceK213265 Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −8 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −7 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −6 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −5 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −4 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −3 | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| −2 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
| −1 | K180660 | Avanti | Optovue, Inc. | 2018 | — |
| 0 (this device) | K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | 2022 | — |
| +1 | K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K180660 | AvantiSummary page 5…ice The CASIA2 is substantially equivalent to the following legally marketed device: 510(k) Number Trade name Product code K180660 RTVue XR OCT Avanti with AngioVue Software OBO, HLI The predicate device is hereinafter called the Avanti.… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | 2025 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K250553 (Tomey Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K180660.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Tomey Cornea/Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging of ocular structures in the anterior segment. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.
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/K213265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213265: Tomey Cornea/Anterior Segment OCT CASIA2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213265
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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