510(k) · Cleared
ClearedOptos Oct/Slo Microperimeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optos Plc. · OBO Tomography, Optical Coherence
Cleared on Feb 22, 2013 as substantially equivalent to K023719 (Nidek Technologies Srl, 2002) after a 323-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Feb 22, 2013
- Review
- 323 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941234 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 3 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 2 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 1 generation backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- This deviceK121043 Optos Oct/Slo MicroperimeterOptos Plc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −3 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −2 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −1 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| 0 (this device) | K121043 | Optos Oct/Slo Microperimeter | Optos Plc. | 2013 | — |
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 |
|---|---|---|---|
| * | K023719 | MP-1 Micro PerimeterSummary page 3…raise any new questions of safety and eflactiveness. Thus, the Optos OCT/SLO Microperimeter issubstantially equivalent to the legally marketed Nidek MP-1 Microperirmter (K02371 9) \\DC -M619WbM -4193W… | 2002 |
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 18 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K023719.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Optos spectral OCTSLO Micorperimeter is indicated for use for in vivo viewing, axial cross section, and three dimensional imaging and measurement of posterior ocular structures including retina, macula, retinal 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 of the eye. In addition, cornea scleraa dn conjunctiva can be imaged with the system by changing the focal position.
The micorperimetry functionality is indicated for use as a fixation examiner locating the patient's subjective answer to light stimuli, generating a sensitivity map of the inspected retinal region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121043: Optos Oct/Slo Microperimeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121043
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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