510(k) · Cleared
Recalled · 2012Rtvue Cam with Corneal Power Upgrade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optovue, Inc. · OBO Tomography, Optical Coherence
Cleared on Sep 8, 2011 as substantially equivalent to K071250 (Optovue, Inc., 2007) and 1 other predicate after a 100-day review. Its family tree reaches back 5 generations to 2002. 8 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 2011
- Review
- 100 days
- Class
- Class II
- Product code
- OBO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K012727 (2002). 11 ancestors in all, the oldest K955442 (1996). 8 later devices descend from it, 2 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 deviceK111505 Rtvue Cam with Corneal Power UpgradeOptovue, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK180660 AvantiOptovue, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK222166 SOLIXOptovue, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK213265 Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation · 2022
- Descendant · cites it directly · 1 of its ownK121622 Nidek RS-3000Nidek Co., Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK251848 Pentacam® Cornea OCTOculus Optikgeräte GmbH · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K180660AvantiOptovue, Inc. · 2018 · cites it directly5descendants
- K222166SOLIXOptovue, Inc. · 2022 · 2 generations on1descendant
- K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation · 2022 · 2 generations on1descendant
- K121622Nidek RS-3000Nidek Co., Ltd. · 2013 · cites it directly1descendant
- K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH · 2026 · 3 generations on0descendants
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) | K111505 | Rtvue Cam with Corneal Power Upgrade | Optovue, Inc. | 2011 | — |
| +1 | K180660 | Avanti | Optovue, Inc. | 2018 | — |
| +2 | K222166 | SOLIX | Optovue, Inc. | 2022 | — |
| +2 | K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | 2022 | — |
| +1 | K121622 | Nidek RS-3000 | Nidek Co., Ltd. | 2013 | — |
| +3 | K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 2…Page 1 of 4 opt~vue Optovue RTVue CAM with Corneal Power 51 0(K) Premarket Notification Predicate Devices (1) RTVue/CAM Module (K07 1250)-manufactured by Optovue, Inc. (2) Pentacam Scheimpflug Camera (K0307 19) - manufactured by Oculus Intended Use The CA… | 2007 |
| * | K030719 | Pentacam Scheimpflug CameraSummary page 2…Corneal Power 51 0(K) Premarket Notification Predicate Devices (1) RTVue/CAM Module (K07 1250)-manufactured by Optovue, Inc. (2) Pentacam Scheimpflug Camera (K0307 19) - manufactured by Oculus Intended Use The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicat… | 2003 |
| † | K101505 | Rtvue Model Rtvue 100 | 2010 |
What descends from it? (8)
2 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 |
|---|---|---|---|---|
| Feb 21, 2012 | Not classified | Z-1340-2012 | Employee error | A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K180660 (Optovue, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K071250.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye, including pachymetry and comneal power.
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/K111505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111505: Rtvue Cam with Corneal Power Upgrade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111505
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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