510(k) · Cleared
ClearedKowa VX-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kowa Co., Ltd. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Oct 6, 2005 as substantially equivalent to K980246 (Canon USA, Inc., 1998) and 1 other predicate after a 321-day review. Its family tree reaches back 2 generations to 1995. 31 later devices descend from it.
- Decided
- Oct 6, 2005
- Review
- 321 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K941234 (1995). 3 ancestors in all. 31 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 1 generation backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- This deviceK043213 Kowa VX-10Kowa Co., Ltd. · 2005
- Descendant · cites it directly · 30 of its ownK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
- Descendant · cites it directly · 28 of its ownK100207 Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010
- Descendant · 2 generations on · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · 2 generations on · 11 of its ownK123460 TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK161509 3D OCT-1 MaestroTopcon Corporation · 2016
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K090115Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009 · cites it directly30descendants
- K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010 · cites it directly28descendants
- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · 2 generations on13descendants
- K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013 · 2 generations on11descendants
- K1615093D OCT-1 MaestroTopcon Corporation · 2016 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −1 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| 0 (this device) | K043213 | Kowa VX-10 | Kowa Co., Ltd. | 2005 | — |
| +1 | K090115 | Retina Camera TRC-NW7SF Mark II | Topcon Corp. | 2009 | — |
| +1 | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8F | Topcon Corp. | 2010 | — |
| +2 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +2 | K123460 | TRC-NW300 Non-Mydriatic Retinal Camera | Topcon Medical Systems, Inc. | 2013 | — |
| +3 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NMSummary page 5…hnology features equivalent to the Predicate Device Manufacturer 510(k)No. Date Cleared Non-Mydriatic Retinal CANON U.S.A., Inc. K980246 05/06/1998 Camera, Model Cr6-45nm KOWA PROFESSIONAL Kowa Optirned, Inc. K954780 12/01/1995 FUNDUS… | 1998 |
| * | K954780 | Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500CSummary page 5…ate Cleared Non-Mydriatic Retinal CANON U.S.A., Inc. K980246 05/06/1998 Camera, Model Cr6-45nm KOWA PROFESSIONAL Kowa Optirned, Inc. K954780 12/01/1995 FUNDUS CAMERA MODEL FX-500 predicate devices, and also delivers the equivalent level of safety. Thus it is conc… | 1995 |
What descends from it? (31)
See all 312 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 10 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090115 (Topcon Corp., 2009) has gone furthest, with 30 descendants of its own.
- 4 other devices also cite its predicate K980246.
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 | — |
What is it indicated for?
Kowa VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K043213 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043213: Kowa VX-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043213
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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