510(k) · Cleared
ClearedKowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kowa Optimed, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Dec 1, 1995 after a 45-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 40 later devices descend from it.
- Decided
- Dec 1, 1995
- Review
- 45 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 3 citing it directly.
- This deviceK954780 Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500CKowa Optimed, Inc. · 1995
- Descendant · cites it directly · 31 of its ownK043213 Kowa VX-10Kowa Co., Ltd. · 2005
- Descendant · 2 generations on · 30 of its ownK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
- Descendant · 2 generations on · 28 of its ownK100207 Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010
- Descendant · 3 generations on · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · 3 generations on · 11 of its ownK123460 TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K043213Kowa VX-10Kowa Co., Ltd. · 2005 · cites it directly31descendants
- K090115Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009 · 2 generations on30descendants
- K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010 · 2 generations on28descendants
- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · 3 generations on13descendants
- K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954780 | Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C | Kowa Optimed, Inc. | 1995 | — |
| +1 | K043213 | Kowa VX-10 | Kowa Co., Ltd. | 2005 | — |
| +2 | K090115 | Retina Camera TRC-NW7SF Mark II | Topcon Corp. | 2009 | — |
| +2 | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8F | Topcon Corp. | 2010 | — |
| +3 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +3 | K123460 | TRC-NW300 Non-Mydriatic Retinal Camera | Topcon Medical Systems, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2026 | 1 | 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 12.8 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (40)
See all 403 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?
- Of its descendants, K043213 (Kowa Co., Ltd., 2005) has gone furthest, with 31 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/K954780 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954780: Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954780
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026