510(k) · Cleared
ClearedRtvue XR Oct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optovue, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Apr 3, 2012 as substantially equivalent to K101505 (Optovue, Inc., 2010) after a 68-day review. Its family tree reaches back 6 generations to 2002. 17 later devices descend from it.
- Decided
- Apr 3, 2012
- Review
- 68 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K012727 (2002). 8 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 5 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 4 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 3 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 2 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 1 generation backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- This deviceK120238 Rtvue XR OctOptovue, Inc. · 2012
- Descendant · cites it directly · 16 of its ownK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- Descendant · 2 generations on · 8 of its ownK181594 Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH · 2018 · Recalled
- Descendant · 3 generations on · 7 of its ownK182569 Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018
- Descendant · 4 generations on · 6 of its ownK192391 Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019
- Descendant · 5 generations on · 5 of its ownK201252 Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016 · cites it directly16descendants
- K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH · 2018 · 2 generations on8descendants
- K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018 · 3 generations on7descendants
- K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019 · 4 generations on6descendants
- K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH · 2020 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −5 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −4 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −3 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −2 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −1 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| 0 (this device) | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| +1 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
| +2 | K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH | 2018 | 2 |
| +3 | K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Heidelberg Engineering GmbH | 2018 | — |
| +4 | K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | 2019 | — |
| +5 | K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 HLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K101505 | Rtvue Model Rtvue 100Summary page 1…Optical Coherence Tomography (OCT) Classification Name: Ophthalmoscope, a-c powered (21 C.F.R. § 886.1570) Predicate Devices 510(k) K101505 RiVue with NDB Optical Coherence Tomography (OCT) Purpose of the Special 510(k) notice The RiVue XR OCT is an upgrade to the… | 2010 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue Software | 2016 | 16 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K153080 (Optovue, Inc., 2016) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K101505.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
MAUDE reports naming product code HLI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 36 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 4 | 112 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RTVue XR with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician.
The RTVue XR with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber layer, and optic disk measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120238 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120238: Rtvue XR Oct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120238
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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