510(k) · Cleared
ClearedCirrus HD-Oct, Model 4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Jan 26, 2007 after a 79-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.
- Decided
- Jan 26, 2007
- Review
- 79 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 2 citing it directly.
- This deviceK063378 Cirrus HD-Oct, Model 4000Carl Zeiss Meditec, Inc. · 2007
- Descendant · cites it directly · 29 of its ownK083291 Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative…Carl Zeiss Meditec, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 24 of its ownK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- Descendant · 2 generations on · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · 3 generations on · 11 of its ownK150977 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015
- Descendant · 4 generations on · 7 of its ownK161194 PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K083291Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000Carl Zeiss Meditec, Inc. · 2009 · cites it directly29descendants
- K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · 2 generations on24descendants
- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · 2 generations on13descendants
- K150977Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015 · 3 generations on11descendants
- K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063378 | Cirrus HD-Oct, Model 4000 | Carl Zeiss Meditec, Inc. | 2007 | — |
| +1 | K083291 | Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases… | Carl Zeiss Meditec, Inc. | 2009 | 2 |
| +2 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| +2 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +3 | K150977 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2015 | — |
| +4 | K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | — | Stratus OCT with Retinal Nerve Fiber Layer Normative and Macula Database Named without a submission number | |
| * | — | Visante OCT Named without a submission number |
What descends from it? (35)
See all 352 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?
- Of its descendants, K083291 (Carl Zeiss Meditec, Inc., 2009) has gone furthest, with 29 descendants of its own.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 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 posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. 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/K063378 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063378: Cirrus HD-Oct, Model 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063378
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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