510(k) · Cleared
ClearedKowa VX-10I
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 Nov 1, 2006 after a 107-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Nov 1, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK062021 Kowa VX-10IKowa Co., Ltd. · 2006
- Descendant · cites it directly · 7 of its ownK091683 Kowa VX-10 aKowa Co., Ltd. · 2009
- Descendant · 2 generations on · 6 of its ownK112330 Kowa VX-20Kowa Co., Ltd. · 2012
- Descendant · 3 generations on · 2 of its ownK200254 Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics · 2020
- Descendant · 3 generations on · 2 of its ownK180526 Eidon FACentervue S.P.A. · 2018
- Descendant · 4 generations on · 1 of its ownK231230 Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K091683Kowa VX-10 aKowa Co., Ltd. · 2009 · cites it directly7descendants
- K112330Kowa VX-20Kowa Co., Ltd. · 2012 · 2 generations on6descendants
- K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics · 2020 · 3 generations on2descendants
- K180526Eidon FACentervue S.P.A. · 2018 · 3 generations on2descendants
- K231230Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062021 | Kowa VX-10I | Kowa Co., Ltd. | 2006 | — |
| +1 | K091683 | Kowa VX-10 a | Kowa Co., Ltd. | 2009 | — |
| +2 | K112330 | Kowa VX-20 | Kowa Co., Ltd. | 2012 | — |
| +3 | K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | 2020 | — |
| +3 | K180526 | Eidon FA | Centervue S.P.A. | 2018 | — |
| +4 | K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091683 | Kowa VX-10 a | 2009 | 7 |
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, K091683 (Kowa Co., Ltd., 2009) has gone furthest, with 7 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 | — |
What is it indicated for?
KOWA VX -10i is intended for taking pictures of fundus images with mydriatic or without mydriatic.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062021: Kowa VX-10I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062021
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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