510(k) · Cleared
ClearedDRSplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centervue S.P.A. · MYC Ophthalmoscope, Laser, Scanning
Cleared on Dec 21, 2021 as substantially equivalent to K192113 (Centervue S.P.A., 2019) after a 27-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Dec 21, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K941234 (1995). 22 ancestors in all, the oldest K810880 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 5 generations between
- 3 generations backK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- 2 generations backK142047 EIDONCentervue S.P.A. · 2014
- 1 generation backK192113 DRSplusCentervue S.P.A. · 2019
- This deviceK213705 DRSplusCentervue S.P.A. · 2021
Show all 9 generations
- Root · 9 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 8 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 7 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 6 generations backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 5 generations backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- 4 generations backK070231 ORIONNidek Technologies Srl · 2007
- 3 generations backK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- 2 generations backK142047 EIDONCentervue S.P.A. · 2014
- 1 generation backK192113 DRSplusCentervue S.P.A. · 2019
- This deviceK213705 DRSplusCentervue S.P.A. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −8 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −7 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −6 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −5 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| −4 | K070231 | ORION | Nidek Technologies Srl | 2007 | — |
| −3 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| −2 | K142047 | EIDON | Centervue S.P.A. | 2014 | — |
| −1 | K192113 | DRSplus | Centervue S.P.A. | 2019 | — |
| 0 (this device) | K213705 | DRSplus | Centervue S.P.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 MYC? 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 MYC device
- #1 K261255 Kowa FM-600score 12.3 · 2 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.
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 26 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 22 ancestors has a recall of any class.
How does its category compare?
All MYC devicesMYC Ophthalmoscope, Laser, Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MYC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYC
116in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYC
No recall names MYC since 2007.
Adverse event reports per year · MYC
2in 2023
MAUDE reports naming product code MYC, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 116 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color and infrared imaging of a human retina without the use of a mydriatic agent.
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/K213705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213705: DRSplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213705
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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