510(k) · Cleared
ClearedCIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · OBO Tomography, Optical Coherence
Cleared on Jan 19, 2012 as substantially equivalent to K083291 (Carl Zeiss Meditec, Inc., 2009) and 2 other predicates after a 269-day review. Its family tree reaches back 6 generations to 2002. 24 later devices descend from it.
- Decided
- Jan 19, 2012
- Review
- 269 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K012727 (2002). 22 ancestors in all, the oldest K946058 (1995). 24 later devices descend from it, 6 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 deviceK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- Descendant · cites it directly · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK150977 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK161194 PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK181534 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · cites it directly13descendants
- K150977Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015 · cites it directly11descendants
- K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016 · 2 generations on7descendants
- K181534Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2019 · 2 generations on6descendants
- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · 2 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) | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| +1 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +1 | K150977 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2015 | — |
| +2 | K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | 2016 | 1 |
| +2 | K181534 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2019 | 2 |
| +2 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K083291 | Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000Summary page 1…400 and 4000 PREDICATE DEVICE Company: Carl Zeiss Meditee, Inc. Device: CirruSTm HD-OCT (K083291) 510(k) Premnarket Notifcation Cirrus ND-OCT with RNFL, Macu… | 2009 |
| * | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA Our reading of the summary gave K100223, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Spectralis HRA+OCT”. | 2010 |
| * | K101505 | Rtvue Model Rtvue 100Summary page 2…SpectralisTM HRA+OCT (KlO0 1223) Company: Optovue, Inc. Device: RTVue with Normative Database (K1 01505) INTENDED USE The CirrusTm RD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative… | 2010 |
What descends from it? (24)
See all 246 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)
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 1.3 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K112184 (Carl Zeiss Meditec, Inc., 2012) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K083291.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The Cirrus normative databases are quantitative tools for the comparison of retinal…
Read the full statement (124 words)
The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The Cirrus normative databases are quantitative tools for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The Cirrus HD-OCT is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111157
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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