510(k) · Cleared
Recalled · Class II · 2012Rtvue Model Rtvue 100
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 Sep 15, 2010 as substantially equivalent to K071250 (Optovue, Inc., 2007) and 1 other predicate after a 106-day review. Its family tree reaches back 5 generations to 2002. 58 later devices descend from it. It has been recalled once.
- Decided
- Sep 15, 2010
- Review
- 106 days
- Class
- Class II
- Product code
- HLI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K012727 (2002). 7 ancestors in all. 58 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 4 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 3 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 2 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 1 generation backK071250 CA, Model: CamOptovue, Inc. · 2007
- This deviceK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010
- Descendant · cites it directly · 24 of its ownK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- Descendant · cites it directly · 17 of its ownK120238 Rtvue XR OctOptovue, Inc. · 2012
- Descendant · 2 generations on · 16 of its ownK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- Descendant · cites it directly · 14 of its ownK121739 Ivue with Normative DatabaseOptovue, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · cites it directly24descendants
- K120238Rtvue XR OctOptovue, Inc. · 2012 · cites it directly17descendants
- K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016 · 2 generations on16descendants
- K121739Ivue with Normative DatabaseOptovue, Inc. · 2013 · cites it directly14descendants
- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −4 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −3 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −2 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −1 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| 0 (this device) | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | — |
| +1 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| +1 | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| +2 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
| +1 | K121739 | Ivue with Normative Database | Optovue, Inc. | 2013 | 3 |
| +2 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K071250 | CA, Model: CamSummary page 1…Optical Coherence Tomography (OCT) Classification Name: Ophthalmoscope, a-c powered (21 CFR§ 886.1570) Predicate Device (1) RTVue with CA (K071250) - Manufactured by Optovue, Inc. (2) StratusOCT with RNFL & Macula Normative Database (K033 123) - manufactured by Carl… | 2007 |
| * | K033123 | Stratusoct with RNFL & Macula Normative DatabaseSummary page 1…wered (21 CFR§ 886.1570) Predicate Device (1) RTVue with CA (K071250) - Manufactured by Optovue, Inc. (2) StratusOCT with RNFL & Macula Normative Database (K033 123) - manufactured by Carl Zeiss Meditec, Inc. Intended Use The RTVue with Normative Database is an optical coherence t… | 2004 |
What descends from it? (58)
See all 584 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2012 | Class II | Z-0024-2013 | No Marketing Application | Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K111157 (Carl Zeiss Meditec, Inc., 2012) has gone furthest, with 24 descendants of its own.
- 4 other devices also cite its predicate K071250.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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 disk as an aid in the diagnosis and management of retinal disease. The
RTVue 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/K101505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101505: Rtvue Model Rtvue 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101505
Report an extraction error
Are you the manufacturer?
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