510(k) · Cleared
ClearedNidek RS-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Co., Ltd. · OBO Tomography, Optical Coherence
Cleared on Mar 14, 2013 as substantially equivalent to K101505 (Optovue, Inc., 2010) and 2 other predicates after a 286-day review. Its family tree reaches back 6 generations to 2002. 1 later device descends from it.
- Decided
- Mar 14, 2013
- Review
- 286 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K012727 (2002). 15 ancestors in all, the oldest K955442 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 5 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 4 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 3 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 2 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 1 generation backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- This deviceK121622 Nidek RS-3000Nidek Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK132323 RS-3000 AdvanceNidek Co., Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132323RS-3000 AdvanceNidek Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −5 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −4 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −3 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −2 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −1 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| 0 (this device) | K121622 | Nidek RS-3000 | Nidek Co., Ltd. | 2013 | — |
| +1 | K132323 | RS-3000 Advance | Nidek Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K101505 | Rtvue Model Rtvue 100Summary page 2…ce Name: Applicant: 510(k) Premarket Notification number: Classification: FDA Product Code: Establishment Registration number: RTVue with Normative Database Optovue K101505 Class 1l HLI 3005950902 RTVue CAM with Corneal Power Measurement Optovue K111505 Class Il 0BO, MMQ 3005950902 Cirrus HD-… | 2010 |
| * | K111505 | Rtvue Cam with Corneal Power UpgradeSummary page 2…ct Code: Establishment Registration number: RTVue with Normative Database Optovue K101505 Class 1l HLI 3005950902 RTVue CAM with Corneal Power Measurement Optovue K111505 Class Il 0BO, MMQ 3005950902 Cirrus HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Database Carl Zeiss K083291… | 2011 |
| * | K083291 | Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000Summary page 2…with Corneal Power Measurement Optovue K111505 Class Il 0BO, MMQ 3005950902 Cirrus HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Database Carl Zeiss K083291 Class Il HLI 2918630 A/Z/622Z K121622 510(k) Summary , 3 GENERAL DEVICE DESCRIPTION The Nidek Optical Cohere… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132323 | RS-3000 Advance | 2014 | 0 |
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 11 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K132323 (Nidek Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K101505.
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 Nidek Optical Coherence Tomography RS-3000 including scanning laser ophthalmoscope function with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
* the retina, retinal nerve fiber layer, and optic disc, and
* the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter),
as an aid in the diagnosis and management of adults having or suspected of having ocular disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121622: Nidek RS-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121622
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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