510(k) · Cleared
ClearedSPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heidelberg Engineering GmbH · OBO Tomography, Optical Coherence
Cleared on May 7, 2026 as substantially equivalent to K250868 (Heidelberg Engineering GmbH, 2025) and 1 other predicate after a 157-day review. Its family tree reaches back 15 generations to 2002.
- Decided
- May 7, 2026
- Review
- 157 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K012727 (2002). 34 ancestors in all, the oldest K946058 (1995). No later device cites it as a predicate yet.
- Root · 15 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 11 generations between
- 3 generations backK223557 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2023
- 2 generations backK240221 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2024
- 1 generation backK250868 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2025
- This deviceK253837 SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH · 2026
Show all 15 generations
- Root · 15 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 14 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 13 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 12 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 11 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 10 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 9 generations backK120238 Rtvue XR OctOptovue, Inc. · 2012
- 8 generations backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- 7 generations backK181594 Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH · 2018 · Recalled
- 6 generations backK182569 Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018
- 5 generations backK192391 Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019
- 4 generations backK201252 Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH · 2020
- 3 generations backK223557 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2023
- 2 generations backK240221 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2024
- 1 generation backK250868 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2025
- This deviceK253837 SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −14 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −13 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −12 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −11 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −10 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −9 | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| −8 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
| −7 | K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH | 2018 | 2 |
| −6 | K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Heidelberg Engineering GmbH | 2018 | — |
| −5 | K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | 2019 | — |
| −4 | K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | 2020 | — |
| −3 | K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2023 | — |
| −2 | K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2024 | — |
| −1 | K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2025 | — |
| 0 (this device) | K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2026 | — |
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 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K250868 | SPECTRALIS HRA+OCT and variantsSummary page 6…l 510(k): SPECTRALIS K253837 Page 1 of 23 PREDICATE DEVICES SPECTRALIS HRA+OCT and variants (K250868), Heidelberg Engineering GmbH; SPECTRALIS with Flex Module (K241163), Heidelberg Engineering GmbH REFERENCE DEVICE CIRRUS HD-OC… | 2025 |
| * | K241163 | SPECTRALIS with Flex ModuleSummary page 6…Page 1 of 23 PREDICATE DEVICES SPECTRALIS HRA+OCT and variants (K250868), Heidelberg Engineering GmbH; SPECTRALIS with Flex Module (K241163), Heidelberg Engineering GmbH REFERENCE DEVICE CIRRUS HD-OCT 5000 (K150977), Carl Zeiss Meditec Inc. INDICATIONS FOR USE SPEC… | 2024 |
| † | K150977 | Cirrus HD-Oct | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 4 of the 34 ancestors have a recall of any class.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for: * viewing the posterior segment of the eye, including two- and three- dimensional imaging * cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT) * fundus imaging * fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA) * autofluorescence imaging * performing measurements of ocular anatomy and…
Read the full statement (283 words)
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:
* viewing the posterior segment of the eye, including two- and three- dimensional imaging
* cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
* fundus imaging
* fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
* autofluorescence imaging
* performing measurements of ocular anatomy and ocular lesions.
The device is indicated as an aid in the detection and management of various ocular diseases, including:
* age-related macular degeneration
* macular edema
* diabetic retinopathy
* retinal and choroidal vascular diseases
* glaucoma
The device is indicated for viewing geographic atrophy.
The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
* a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects - the classification result being valid only for Caucasian subjects
* a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)
The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.
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/K253837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253837: SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253837
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026