510(k) · Cleared
ClearedSpectral Oct/Slo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opko Health, Inc. · OBO Tomography, Optical Coherence
Cleared on Nov 14, 2008 as substantially equivalent to K042885 (Ophthalmic Technologies, Inc., 2005) and 1 other predicate after a 268-day review. Its family tree reaches back 3 generations to 2002. 4 later devices descend from it.
- Decided
- Nov 14, 2008
- Review
- 268 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K012727 (2002). 5 ancestors in all, the oldest K943956 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 2 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 1 generation backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- This deviceK080460 Spectral Oct/SloOpko Health, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK173707 P200TEOptos Plc. · 2018
- Descendant · 2 generations on · 1 of its ownK231673 P200TE (A10700)Optos Plc. · 2023
- Descendant · 3 generations on · 0 of its ownK233602 P200TE (A10700)Optos Plc. · 2024
- Descendant · 2 generations on · 0 of its ownK190732 P200TxEOptos Plc. · 2019
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −2 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −1 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| 0 (this device) | K080460 | Spectral Oct/Slo | Opko Health, Inc. | 2008 | — |
| +1 | K173707 | P200TE | Optos Plc. | 2018 | — |
| +2 | K231673 | P200TE (A10700) | Optos Plc. | 2023 | — |
| +3 | K233602 | P200TE (A10700) | Optos Plc. | 2024 | — |
| +2 | K190732 | P200TxE | Optos Plc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K042885 | Oct-OpthalmoscopeSummary page 1…Ophthahnoscope using optical coherence tomography Classification Name: Ophthalmoscope, a-c powered, 890HLI 3. Equivalent legally marketed devices. K042885 OCT Ophthalmoscope, Ophthahmic Techlologies, Inc K033123 Stratus OCT, Carl Zeiss Meditec System 4. Description… | 2005 |
| * | K033123 | Stratusoct with RNFL & Macula Normative DatabaseSummary page 1…fication Name: Ophthalmoscope, a-c powered, 890HLI 3. Equivalent legally marketed devices. K042885 OCT Ophthalmoscope, Ophthahmic Techlologies, Inc K033123 Stratus OCT, Carl Zeiss Meditec System 4. Description The OPKO/OTI Spectral OCT/SLO is a computerized instrumnent that… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173707 | P200TE | 2018 | 3 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K173707 (Optos Plc., 2018) has gone furthest, with 3 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. 2008, 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 Spectral OCT/SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device. It is indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures including: retina, macula, retina nerve fibre layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye. In addition, cornea, sclera and conjunctiva can be imaged with the system by changing the focal position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080460 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080460: Spectral Oct/Slo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080460
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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