510(k) · Cleared
ClearedSpectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
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 Nov 1, 2017 as substantially equivalent to K152205 (Heidelberg Engineering GmbH, 2016) after a 57-day review. Its family tree reaches back 7 generations to 1995. 13 later devices descend from it.
- Decided
- Nov 1, 2017
- Review
- 57 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K941234 (1995). 16 ancestors in all, the oldest K946058 (1995). 13 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 6 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 5 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 4 generations backK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- 3 generations backK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
- 2 generations backK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
- 1 generation backK152205 Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT…Heidelberg Engineering GmbH · 2016
- This deviceK172649 Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis…Heidelberg Engineering GmbH · 2017
- Descendant · cites it directly · 8 of its ownK181594 Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH · 2018 · Recalled
- Descendant · 2 generations on · 7 of its ownK182569 Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018
- Descendant · 3 generations on · 6 of its ownK192391 Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019
- Descendant · 4 generations on · 5 of its ownK201252 Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH · 2020
- Descendant · 5 generations on · 4 of its ownK223557 SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH · 2018 · cites it directly8descendants
- K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH · 2018 · 2 generations on7descendants
- K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH · 2019 · 3 generations on6descendants
- K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH · 2020 · 4 generations on5descendants
- K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2023 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −6 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −5 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −4 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| −3 | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
| −2 | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra… | Heidelberg Engineering | 2010 | — |
| −1 | K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis… | Heidelberg Engineering GmbH | 2016 | — |
| 0 (this device) | K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT… | Heidelberg Engineering GmbH | 2017 | — |
| +1 | K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH | 2018 | 2 |
| +2 | K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Heidelberg Engineering GmbH | 2018 | — |
| +3 | K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | 2019 | — |
| +4 | K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | 2020 | — |
| +5 | K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2023 | — |
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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…Summary page 5…SPECTRALIS HRA+OCT and variants Applicant: Heidelberg Engineering GmbH 510(k) Premarket Notification number: K152205 Classification: Class II CFR Title: 21 CFR 886.1570 FDA Product Co… | 2016 |
| † | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA | 2010 |
| † | K121993 | Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis… | 2012 |
| † | K113129 | Spectralis Anterior Segment Module (Spectralis Asm) | 2011 |
What descends from it? (13)
See all 133 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)
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 22 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K181594 (Heidelberg Engineering GmbH, 2018) has gone furthest, with 8 descendants of its own.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT…
Read the full statement (160 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 photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) 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 and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172649: Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172649
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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