510(k) · Cleared
ClearedCR-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 Apr 24, 2008 as substantially equivalent to K031629 (Canon USA, Inc., 2003) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 1995. 17 later devices descend from it.
- Decided
- Apr 24, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K941234 (1995). 6 ancestors in all, the oldest K946058 (1995). 17 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 2 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 1 generation backK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
- This deviceK080883 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 · cites it directly · 5 of its ownK090466 Digital Retinal Camera, CR-1 Mark IICanon, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK102013 Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2010
- Descendant · 2 generations on · 3 of its ownK111612 Digital Retinal CameraCanon, Inc. · 2011
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- 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 · cites it directly5descendants
- K102013Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2010 · 2 generations on4descendants
- K111612Digital Retinal CameraCanon, Inc. · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −2 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −1 | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-Dgi | Canon USA, Inc. | 2003 | — |
| 0 (this device) | 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 | — |
| +1 | K090466 | Digital Retinal Camera, CR-1 Mark II | Canon, Inc. | 2009 | — |
| +2 | K102013 | Digital Retinal Camera | Canon Inc. -Medical Equipment Group | 2010 | — |
| +2 | K111612 | Digital Retinal Camera | Canon, Inc. | 2011 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-DgiSummary page 1…Canon Model Name: CR-DGi Classification Name: 86HKI, Ophthalmic cameras FDA 51 0(k) #: K031629 Manufacturer: Canon Inc. Trade Name: Canon Model Name:… | 2003 |
| * | K063717 | CF-1Summary page 1…Canon Model Name: CF-i Classification Name: 86HKI, Ophthalmic cameras FDA 51 0(k) #: K06371 7 Description Of Device: CR-i is an improved model of CR-DGi. Canon EQS Digital Camera is m… | 2007 |
What descends from it? (17)
See all 172 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 13 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K092565 (Canon Components, Inc., 2010) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K031629.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 without a mydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080883 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080883: CR-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080883
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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