510(k) · Cleared
Cleared60 Fundus Camera CF-60UV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon USA, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Feb 3, 1995 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 93 later devices descend from it.
- Decided
- Feb 3, 1995
- Review
- 87 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
93 later devices descend from it, 2 citing it directly.
- This deviceK946058 60 Fundus Camera CF-60UVCanon USA, Inc. · 1995
- Descendant · cites it directly · 80 of its ownK041546 Digital Fundus Camera, Model CF-60DSICanon, Inc. · 2004
- Descendant · 2 generations on · 63 of its ownK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
- Descendant · 3 generations on · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
- Descendant · cites it directly · 30 of its ownK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
- Descendant · 2 generations on · 28 of its ownK100207 Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K041546Digital Fundus Camera, Model CF-60DSICanon, Inc. · 2004 · cites it directly80descendants
- K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006 · 2 generations on63descendants
- K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · 3 generations on41descendants
- K090115Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009 · cites it directly30descendants
- K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946058 | 60 Fundus Camera CF-60UV | Canon USA, Inc. | 1995 | — |
| +1 | K041546 | Digital Fundus Camera, Model CF-60DSI | Canon, Inc. | 2004 | — |
| +2 | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
| +3 | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra… | Heidelberg Engineering | 2010 | — |
| +1 | K090115 | Retina Camera TRC-NW7SF Mark II | Topcon Corp. | 2009 | — |
| +2 | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8F | Topcon Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (93)
See all 932 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?
- Of its descendants, K041546 (Canon, Inc., 2004) has gone furthest, with 80 descendants of its own.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K946058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946058: 60 Fundus Camera CF-60UV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946058
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026