510(k) · Cleared
ClearedKowa VX-20
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 Feb 16, 2012 as substantially equivalent to K091683 (Kowa Co., Ltd., 2009) and 1 other predicate after a 188-day review. Its family tree reaches back 5 generations to 1995. 6 later devices descend from it.
- Decided
- Feb 16, 2012
- Review
- 188 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K941234 (1995). 10 ancestors in all, the oldest K946058 (1995). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 4 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 3 generations backK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
- 2 generations backK080883 CR-1Canon, Inc. · 2008
- 1 generation backK092565 Digital Retinal Camera CX-1Canon Components, Inc. · 2010
- This deviceK112330 Kowa VX-20Kowa Co., Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK200254 Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics · 2020
- Descendant · cites it directly · 2 of its ownK180526 Eidon FACentervue S.P.A. · 2018
- Descendant · 2 generations on · 1 of its ownK231230 Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK211328 Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A. · 2021
- Descendant · 3 generations on · 0 of its ownK250770 Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics · 2020 · cites it directly2descendants
- K180526Eidon FACentervue S.P.A. · 2018 · cites it directly2descendants
- K231230Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. · 2023 · 2 generations on1descendant
- K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A. · 2021 · 2 generations on1descendant
- K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −4 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −3 | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-Dgi | Canon USA, Inc. | 2003 | — |
| −2 | K080883 | CR-1 | Canon, Inc. | 2008 | — |
| −1 | K092565 | Digital Retinal Camera CX-1 | Canon Components, Inc. | 2010 | — |
| 0 (this device) | K112330 | Kowa VX-20 | Kowa Co., Ltd. | 2012 | — |
| +1 | K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | 2020 | — |
| +1 | K180526 | Eidon FA | Centervue S.P.A. | 2018 | — |
| +2 | K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2023 | — |
| +2 | K211328 | Eidon FA, Eidon, Eidon AF, Eidon Uwfl | Centervue S.P.A. | 2021 | — |
| +3 | K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 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 12.7 · 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 |
|---|---|---|---|
| * | K091683 | Kowa VX-10 aSummary page 1…KI, NFJ Identification of predicate devices: Kowa Company believes that this device is substantially equivalent to: KOWA VX-lIOct manufactured by Kowa, 5 10(k)# K09 1683, Canon CX-lI Retinal Camera manufactured by Canon, 51lO(k)# K092565. Device description: The KOWA VX-20 is a retinal ima… | 2009 |
| * | K092565 | Digital Retinal Camera CX-1Summary page 1…device is substantially equivalent to: KOWA VX-lIOct manufactured by Kowa, 5 10(k)# K09 1683, Canon CX-lI Retinal Camera manufactured by Canon, 51lO(k)# K092565. Device description: The KOWA VX-20 is a retinal image shooting device which can take images with Mydriatic, Non-mydriatic, Fluo… | 2010 |
What descends from it? (6)
2 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 17 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K200254 (Optina Diagnostics, 2020) has gone furthest, with 2 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. 2012, 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 KOWA VX-20 is intended for taking pictures of retinal 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/K112330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112330: Kowa VX-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112330
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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