510(k) · Cleared
ClearedNon-Mydriatic Retinal Camera
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 Jun 7, 1995 after a 449-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 121 later devices descend from it.
- Decided
- Jun 7, 1995
- Review
- 449 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
121 later devices descend from it, 1 citing it directly.
- This deviceK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- Descendant · cites it directly · 120 of its ownK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- Descendant · 2 generations on · 96 of its ownK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- Descendant · 2 generations on · 92 of its ownK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
- Descendant · 2 generations on · 79 of its ownK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- Descendant · 3 generations on · 63 of its ownK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · See all- K980246Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998 · cites it directly120descendants
- K014274Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002 · 2 generations on96descendants
- K031629Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003 · 2 generations on92descendants
- K041367Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004 · 2 generations on79descendants
- K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006 · 3 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| +1 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| +2 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| +2 | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-Dgi | Canon USA, Inc. | 2003 | — |
| +2 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| +3 | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 8 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (121)
See all 1211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | 1998 | 120 |
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, K980246 (Canon USA, Inc., 1998) has gone furthest, with 120 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/K941234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941234: Non-Mydriatic 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/K941234
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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