510(k) · Cleared
Recalled · 2011Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000
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 May 5, 2009 as substantially equivalent to K063378 (Carl Zeiss Meditec, Inc., 2007) and 2 other predicates after a 179-day review. Its family tree reaches back 3 generations to 2002. 29 later devices descend from it. It has been recalled 2 times.
- Decided
- May 5, 2009
- Review
- 179 days
- Class
- Class II
- Product code
- OBO
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K012727 (2002). 5 ancestors in all. 29 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 2 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 1 generation backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- This deviceK083291 Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative…Carl Zeiss Meditec, Inc. · 2009
- 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 · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · 2 generations on · 11 of its ownK150977 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK161194 PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 6 of its ownK181534 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2019 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · cites it directly24descendants
- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · cites it directly13descendants
- K150977Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015 · 2 generations on11descendants
- K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016 · 3 generations on7descendants
- K181534Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2019 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −2 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −1 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| 0 (this device) | K083291 | Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases… | Carl Zeiss Meditec, Inc. | 2009 | — |
| +1 | 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 | — |
| +2 | K150977 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2015 | — |
| +3 | K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | 2016 | 1 |
| +3 | K181534 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2019 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 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 |
|---|---|---|---|
| * | K063378 | Cirrus HD-Oct, Model 4000Summary page 1…and Macular Normative Databases PREDICATE DEVICES Company: Carl Zeiss Meditec, Inc. Device: Cirrus TM HD-OCT (K063378) Company: Carl Zeiss Meditec, Inc. Device: StratusOCTTM with Retinal Nerve… | 2007 |
| * | K033123 | Stratusoct with RNFL & Macula Normative DatabaseSummary page 1…Zeiss Meditec, Inc. Device: StratusOCTTM with Retinal Nerve Fiber Layer (RNFL) & Macula Normative Database (K033123) Company: Carl Zeiss Meditec, Inc. Device: Visante OCT (KO51789)… | 2004 |
| * | K051789 | Visante Oct | 2005 |
What descends from it? (29)
See all 294 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 |
|---|---|---|---|---|
| Mar 10, 2011 | Not classified | Z-2126-2011 | Software design | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient |
| Mar 10, 2011 | Not classified | Z-2127-2011 | Software design | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 5 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.
- 1 other device also cites its predicate K063378.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 CirrusTM 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, macula, and optic disc. The Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL) and Macular Normative Databases is a quantitative tool for the comparison…
Read the full statement (118 words)
The CirrusTM 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, macula, and optic disc. The Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL) and Macular Normative Databases is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina 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 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/K083291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083291
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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