510(k) · Cleared
Recalled · Class II · 2026Spectralis HRA+OCT and variants with OCT Angiography 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 Sep 13, 2018 as substantially equivalent to K153080 (Optovue, Inc., 2016) and 1 other predicate after an 87-day review. Its family tree reaches back 8 generations to 2002. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 13, 2018
- Review
- 87 days
- Class
- Class II
- Product code
- OBO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K012727 (2002). 25 ancestors in all, the oldest K946058 (1995). 8 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 7 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 6 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 5 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 4 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 3 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 2 generations backK120238 Rtvue XR OctOptovue, Inc. · 2012
- 1 generation backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- This deviceK181594 Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH · 2018
- Descendant · cites it directly · 7 of its ownK182569 Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018
- Descendant · 2 generations on · 6 of its ownK192391 Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019
- Descendant · 3 generations on · 5 of its ownK201252 Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH · 2020
- Descendant · 4 generations on · 4 of its ownK223557 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2023
- Descendant · 5 generations on · 2 of its ownK240221 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018 · cites it directly7descendants
- K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019 · 2 generations on6descendants
- K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH · 2020 · 3 generations on5descendants
- K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2023 · 4 generations on4descendants
- K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −7 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −6 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −5 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −4 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −3 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −2 | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| −1 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
| 0 (this device) | K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH | 2018 | — |
| +1 | K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Heidelberg Engineering GmbH | 2018 | — |
| +2 | K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | 2019 | — |
| +3 | K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | 2020 | — |
| +4 | K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2023 | — |
| +5 | K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2024 | — |
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 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K153080 | RTVue XR OCT Avanti with AngioVue SoftwareSummary page 6…K181594 PRIMARY PREDICATE DEVICE OptoVue, Inc. RTVue XR OCT Avanti with AngioVue™ Software (K153080), Software Version 2016.1.0 LEGALLY MARKETED UNMODIFIED PREDICATE DEVICE Trade/Device Name: SPECTRAL… | 2016 |
| * | K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Summary page 6…SPECTRALIS HRA+OCT and variants Applicant: Heidelberg Engineering GmbH 510(k) Premarket Notification number: K172649 Classification: Class II CFR Title: 21 CFR 886.1570 FDA Product Co… | 2017 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182569 | Spectralis HRA+OCT and variants with High Magnification Module | 2018 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2026 | Class II | Z-3215-2026 | Component design/selection | Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the… |
| Jul 3, 2019 | Class II | Z-2437-2019 | Under Investigation by firm | Error in the default configuration which could lead to the incorrect display of patient master data. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K182569 (Heidelberg Engineering GmbH, 2018) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K153080.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS…
Read the full statement (242 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 (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• 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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181594: Spectralis HRA+OCT and variants with OCT Angiography Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181594
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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