510(k) · Cleared
ClearedSpectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis Oct Blue Peak, Spectralis Oct
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 Oct 25, 2012 as substantially equivalent to K063191 (Heidelberg Engineering, 2006) and 2 other predicates after a 111-day review. Its family tree reaches back 5 generations to 1995. 15 later devices descend from it.
- Decided
- Oct 25, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941234 (1995). 13 ancestors in all, the oldest K946058 (1995). 15 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 4 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 3 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 2 generations backK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- 1 generation backK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
- This deviceK121993 Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis…Heidelberg Engineering GmbH · 2012
- Descendant · cites it directly · 14 of its ownK152205 Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT…Heidelberg Engineering GmbH · 2016
- Descendant · 2 generations on · 13 of its ownK172649 Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis…Heidelberg Engineering GmbH · 2017
- Descendant · 3 generations on · 8 of its ownK181594 Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH · 2018 · Recalled
- Descendant · 4 generations on · 7 of its ownK182569 Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018
- Descendant · 5 generations on · 6 of its ownK192391 Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…Heidelberg Engineering GmbH · 2016 · cites it directly14descendants
- K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Heidelberg Engineering GmbH · 2017 · 2 generations on13descendants
- K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH · 2018 · 3 generations on8descendants
- K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018 · 4 generations on7descendants
- K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −4 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −3 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −2 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| −1 | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
| 0 (this device) | K121993 | Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct… | Heidelberg Engineering GmbH | 2012 | — |
| +1 | K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis… | Heidelberg Engineering GmbH | 2016 | — |
| +2 | K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT… | Heidelberg Engineering GmbH | 2017 | — |
| +3 | K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH | 2018 | 2 |
| +4 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | K063191 | Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model Hra 2/OctSummary page 2…aucasian subjects. Substantial Equivalence Analysis The Spectralis HRA±OCT has the same intended use and basic technological characteristics as the Heidelberg HRA2/OCT (K063 191). The device has been updated to include new optical layout and components, new electronic components, new mechanical design, and… | 2006 |
| * | K030433 | Stratusoct with RNFL Normative DatabaseSummary page 2…redicate devices incorporating similar technology features to the upgraded Spectralis device include: the STATUS OCT with Retinal Nerve Fiber Layer Normative Database (K(030433) for the similarity in having a normative database, and the IRI Integrated Retinal Imager (K062295) for the auto fluorescence int… | 2003 |
| * | K062295 | Iri Integrated Retinal ImagerSummary page 2…de: the STATUS OCT with Retinal Nerve Fiber Layer Normative Database (K(030433) for the similarity in having a normative database, and the IRI Integrated Retinal Imager (K062295) for the auto fluorescence intended use. Performance - Bench Testing The Spectralis HRA+OCT has been tested according to lEG 606… | 2006 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT… | 2016 | 14 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K152205 (Heidelberg Engineering GmbH, 2016) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K063191.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 HRA±OCT 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, fundus photography, and fluorescence imaging (fluorescein, indocyanine green and autofluorescence), and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various…
Read the full statement (138 words)
The Spectralis HRA±OCT 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, fundus photography, and fluorescence imaging (fluorescein, indocyanine green and autofluorescence), and to perform 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, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The Spectralis HRA+OCT includes a retinal nerve fiber layer thickness normative database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to a database of Caucasian normal subjects; the classification result is valid only for Caucasian subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121993: Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis Oct Blue Peak, Spectralis Oct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121993
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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