510(k) · Cleared
ClearedDigital Retinal Camera
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 Sep 14, 2011 as substantially equivalent to K102013 (Canon Inc. -Medical Equipment Group, 2010) and 1 other predicate after a 97-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 14, 2011
- Review
- 97 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K941234 (1995). 10 ancestors in all, the oldest K946058 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 5 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 4 generations backK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
- 3 generations backK080883 CR-1Canon, Inc. · 2008
- 2 generations backK090466 Digital Retinal Camera, CR-1 Mark IICanon, Inc. · 2009
- 1 generation backK102013 Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2010
- This deviceK111612 Digital Retinal CameraCanon, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK123208 Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2013
- Descendant · 2 generations on · 0 of its ownK201273 ImageSPECTRUMCanon, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK201122 Canon non-mydriatic retinal camera CR seriesCanon, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −5 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −4 | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-Dgi | Canon USA, Inc. | 2003 | — |
| −3 | K080883 | CR-1 | Canon, Inc. | 2008 | — |
| −2 | K090466 | Digital Retinal Camera, CR-1 Mark II | Canon, Inc. | 2009 | — |
| −1 | K102013 | Digital Retinal Camera | Canon Inc. -Medical Equipment Group | 2010 | — |
| 0 (this device) | K111612 | Digital Retinal Camera | Canon, Inc. | 2011 | — |
| +1 | K123208 | Digital Retinal Camera | Canon Inc. -Medical Equipment Group | 2013 | — |
| +2 | K201273 | ImageSPECTRUM | Canon, Inc. | 2020 | — |
| +2 | K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 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 12.7 · 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 |
|---|---|---|---|
| * | K102013 | Digital Retinal CameraSummary page 1…CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: 11 Product Code: HKI FDA 5I1O(k) #: K102013 Trade Name: Canon Digital Retinal Camera CX-I Regulation Number: 21 CFR 886.1120 Regul… | 2010 |
| * | K092565 | Digital Retinal Camera CX-1Summary page 1…CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: 11 Product Code: HKI FDA 510(k) #: K092565 Description of Device: The Digital Retinal Camera CR-2 Plus is used for taking digital images of a human retina wit… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123208 | Digital Retinal Camera | 2013 | 2 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K123208 (Canon Inc. -Medical Equipment Group, 2013) has gone furthest, with 2 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. 2011, 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 CR-2 Plus is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus has the following photography modes: color, red free & cobalt digital filter, and fundus autofluorecence (FAF).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111612: Digital Retinal Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111612
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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