510(k) · Cleared
Recalled · 2009Stratusoct with RNFL 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 May 1, 2003 as substantially equivalent to K012727 (Carl Zeiss Ophthalmic Systems, Inc., 2002) after an 80-day review. Its family tree reaches back 1 generation to 2002. 89 later devices descend from it. It has been recalled once.
- Decided
- May 1, 2003
- Review
- 80 days
- Class
- Class II
- Product code
- HLI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012727 (2002). 89 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- This deviceK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003
- Descendant · cites it directly · 77 of its ownK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 70 of its ownK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- Descendant · 3 generations on · 64 of its ownK071250 CA, Model: CamOptovue, Inc. · 2007
- Descendant · 2 generations on · 58 of its ownK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- Descendant · cites it directly · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 89 · See all- K033123Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · cites it directly77descendants
- K063343Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006 · 2 generations on70descendants
- K071250CA, Model: CamOptovue, Inc. · 2007 · 3 generations on64descendants
- K101505Rtvue Model Rtvue 100Optovue, Inc. · 2010 · 2 generations on58descendants
- K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · cites it directly41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| 0 (this device) | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | — |
| +1 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| +2 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| +3 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| +2 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| +1 | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra… | Heidelberg Engineering | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 10 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K012727 | Humphrey OCT3 | 2002 |
What descends from it? (89)
See all 895 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033123 | Stratusoct with RNFL & Macula Normative Database | 2004 | 77 |
| K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA | 2010 | 41 |
| K121993 | Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis… | 2012 | 15 |
| K082016 | GDX VCC with Ecc Software | 2009 | 1 |
| K071839 | Soct Copernicus, Model 15205 | 2008 | 0 |
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?
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, and optic disk. 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. The STRATUSOCT with…
Read the full statement (125 words)
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, and optic disk. 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. The STRATUSOCT with Retinal Nerve Fiber Layer ("RNFL") Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. The RNFL Normative Database is intended for use as a diagnostic aid in the detection and management of ocular diseases, especially 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/K030433 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030433: Stratusoct with RNFL Normative Database.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030433
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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