510(k) · Cleared
Recalled · 2009Stratusoct with RNFL & Macula Normative Database
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 Apr 20, 2004 as substantially equivalent to K030433 (Carl Zeiss Meditec, Inc., 2003) after a 203-day review. Its family tree reaches back 2 generations to 2002. 77 later devices descend from it. It has been recalled once.
- Decided
- Apr 20, 2004
- Review
- 203 days
- Class
- Class II
- Product code
- HLI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012727 (2002). 77 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 1 generation backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- This deviceK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004
- Descendant · cites it directly · 70 of its ownK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- Descendant · 2 generations on · 64 of its ownK071250 CA, Model: CamOptovue, Inc. · 2007
- Descendant · cites it directly · 58 of its ownK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 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
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K063343Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006 · cites it directly70descendants
- K071250CA, Model: CamOptovue, Inc. · 2007 · 2 generations on64descendants
- K101505Rtvue Model Rtvue 100Optovue, Inc. · 2010 · cites it directly58descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −1 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| 0 (this device) | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | — |
| +1 | 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 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K030433 | Stratusoct with RNFL Normative DatabaseSummary page 3…ministration 9200 Corporate Boulevard MAY 2 9 2007 Rockville MD 20850 Carl Zeiss Meditec, Inc. c/o Ms. Judith A. Brimacombe 5160 Hacienda Drive Dublin, CA 94568 Re: K030433 and K033123 Trade/Device Name: STRATUSocr™ with Retinal Nerve Fiber Layer (RNFL) & Macula Normative Database Regulation Number: 2… | 2003 |
What descends from it? (77)
See all 774 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 |
|---|---|---|---|---|
| Jul 31, 2009 | Not classified | Z-2048-2009 | Software design | Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K063343 (Bioptigen, Inc., 2006) has gone furthest, with 70 descendants of its own.
- 4 other devices also cite its predicate K030433.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 STRATUSOCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The STRATUSOCT with Retinal Nerve Fiber Layer ("RNFL" & Macula Normative Database 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 edema, central serous retinopathy, and glaucoma.
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/K033123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033123: Stratusoct with RNFL & Macula Normative Database.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033123
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