510(k) · Cleared
ClearedCF-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jan 23, 2007 as substantially equivalent to K041546 (Canon, Inc., 2004) after a 40-day review. Its family tree reaches back 2 generations to 1995. 18 later devices descend from it.
- Decided
- Jan 23, 2007
- Review
- 40 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K946058 (1995). 18 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK946058 60 Fundus Camera CF-60UVCanon USA, Inc. · 1995
- 1 generation backK041546 Digital Fundus Camera, Model CF-60DSICanon, Inc. · 2004
- This deviceK063717 CF-1Canon, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK080883 CR-1Canon, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK092565 Digital Retinal Camera CX-1Canon Components, Inc. · 2010
- Descendant · 2 generations on · 6 of its ownK112330 Kowa VX-20Kowa Co., Ltd. · 2012
- Descendant · 2 generations on · 5 of its ownK090466 Digital Retinal Camera, CR-1 Mark IICanon, Inc. · 2009
- Descendant · 3 generations on · 4 of its ownK102013 Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2010
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K080883CR-1Canon, Inc. · 2008 · cites it directly17descendants
- K092565Digital Retinal Camera CX-1Canon Components, Inc. · 2010 · cites it directly14descendants
- K112330Kowa VX-20Kowa Co., Ltd. · 2012 · 2 generations on6descendants
- K090466Digital Retinal Camera, CR-1 Mark IICanon, Inc. · 2009 · 2 generations on5descendants
- K102013Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2010 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946058 | 60 Fundus Camera CF-60UV | Canon USA, Inc. | 1995 | — |
| −1 | K041546 | Digital Fundus Camera, Model CF-60DSI | Canon, Inc. | 2004 | — |
| 0 (this device) | K063717 | CF-1 | Canon, Inc. | 2007 | — |
| +1 | K080883 | CR-1 | Canon, Inc. | 2008 | — |
| +1 | K092565 | Digital Retinal Camera CX-1 | Canon Components, Inc. | 2010 | — |
| +2 | K112330 | Kowa VX-20 | Kowa Co., Ltd. | 2012 | — |
| +2 | K090466 | Digital Retinal Camera, CR-1 Mark II | Canon, Inc. | 2009 | — |
| +3 | K102013 | Digital Retinal Camera | Canon Inc. -Medical Equipment Group | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 12.8 · 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? (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 |
|---|---|---|---|
| * | K041546 | Digital Fundus Camera, Model CF-60DSISummary page 1…Model Name: CF-60DSi Classification Name: 86HKI, Ophthalmic cameras Regulatory Class: Class II FDA 510(k) 4:K041546 Intended Use: CF-I is intended to be used for taking digital images of retina of' bimma eye wi… | 2004 |
What descends from it? (18)
See all 182 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 12 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080883 (Canon, Inc., 2008) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K041546.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The device is intended to be used for taking digital images of retina of human eye with a mydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063717 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063717: CF-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063717
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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