510(k) · Cleared
ClearedDigital Retinal Camera CX-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Components, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Mar 18, 2010 as substantially equivalent to K063717 (Canon, Inc., 2007) and 1 other predicate after a 210-day review. Its family tree reaches back 4 generations to 1995. 14 later devices descend from it.
- Decided
- Mar 18, 2010
- Review
- 210 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K941234 (1995). 7 ancestors in all, the oldest K946058 (1995). 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 3 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 2 generations backK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
- 1 generation backK080883 CR-1Canon, Inc. · 2008
- This deviceK092565 Digital Retinal Camera CX-1Canon Components, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK112330 Kowa VX-20Kowa Co., Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK111612 Digital Retinal CameraCanon, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK200254 Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics · 2020
- Descendant · 2 generations on · 2 of its ownK180526 Eidon FACentervue S.P.A. · 2018
- Descendant · cites it directly · 2 of its ownK123101 TRC-50DX Retinal CameraTopcon Medical Systems, Inc. · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K112330Kowa VX-20Kowa Co., Ltd. · 2012 · cites it directly6descendants
- K111612Digital Retinal CameraCanon, Inc. · 2011 · cites it directly3descendants
- K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics · 2020 · 2 generations on2descendants
- K180526Eidon FACentervue S.P.A. · 2018 · 2 generations on2descendants
- K123101TRC-50DX Retinal CameraTopcon Medical Systems, Inc. · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −3 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −2 | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-Dgi | Canon USA, Inc. | 2003 | — |
| −1 | K080883 | CR-1 | Canon, Inc. | 2008 | — |
| 0 (this device) | K092565 | Digital Retinal Camera CX-1 | Canon Components, Inc. | 2010 | — |
| +1 | K112330 | Kowa VX-20 | Kowa Co., Ltd. | 2012 | — |
| +1 | K111612 | Digital Retinal Camera | Canon, Inc. | 2011 | — |
| +2 | K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | 2020 | — |
| +2 | K180526 | Eidon FA | Centervue S.P.A. | 2018 | — |
| +1 | K123101 | TRC-50DX Retinal Camera | Topcon Medical Systems, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K063717 | CF-1Summary page 1…Canon Model Name: CF-I Classification Name: 86HKI Ophthalmic camera FDA 5IO(k) #: K063717 Trade Name: Canon Model Name: CR-I Classification Name:… | 2007 |
| * | K080883 | CR-1Summary page 1…Trade Name: Canon Model Name: CR-I Classification Name: 86HKI Ophthalmic camera FDA 5 10(k) *:K080883 Description of Device: The DIGITAL RET[NAL CAMERA CX-1 is used for taking digital images of retina of human eye w… | 2008 |
What descends from it? (14)
See all 143 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 15 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K112330 (Kowa Co., Ltd., 2012) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K063717.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 non-mydriatic and mydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092565: Digital Retinal Camera CX-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092565
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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