510(k) · Cleared
ClearedNexy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Next Sight Srl · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jun 8, 2018 as substantially equivalent to K101935 (Centervue S.P.A., 2010) and 1 other predicate after a 126-day review. Its family tree reaches back 7 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 8, 2018
- Review
- 126 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K941234 (1995). 24 ancestors in all, the oldest K810880 (1981). 2 later devices descend from it, 2 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 backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 3 generations backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- 2 generations backK070231 ORIONNidek Technologies Srl · 2007
- 1 generation backK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- This deviceK180306 NexyNext Sight Srl · 2018
- Descendant · cites it directly · 0 of its ownK250683 Resolve Fundus CameraOptain Health, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK202221 VX650Luneau Technology Operations · 2021
Most influential descendants
Showing 2 of 2 · See allView 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 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −3 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| −2 | K070231 | ORION | Nidek Technologies Srl | 2007 | — |
| −1 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| 0 (this device) | K180306 | Nexy | Next Sight Srl | 2018 | — |
| +1 | K250683 | Resolve Fundus Camera | Optain Health, Inc. | 2025 | — |
| +1 | K202221 | VX650 | Luneau Technology Operations | 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 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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 HKI? 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 HKI device
- #1 K253176 TearViewscore 12.7 · 5 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 |
|---|---|---|---|
| * | K101935 | Centervue Digital Retinography SystemSummary page 6…Date Device Holder cleared Name Digital CenterVue K101935 27 October Retinography System DRS… | 2010 |
| * | K120982 | Digital Eye-Fundus CameraSummary page 6…27 October Retinography System DRS 2010 MiiS Horus Medimaging K120982 28 September Scope DEC Integrated 100… | 2012 |
What descends from it? (2)
2 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 23 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K250683 (Optain Health, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K101935.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180306: Nexy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180306
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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