510(k) · Cleared
ClearedModification to Kowa Nonmyd Alpha-Diii
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 Jan 16, 2009 as substantially equivalent to K082767 (Kowa Co., Ltd., 2008) after a 60-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.
- Decided
- Jan 16, 2009
- Review
- 60 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082767 (2008). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K190056KOWA VK-2sKowa Co. Ltd. Chofu · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082767 | Kowa Nonmyd Alpha-Diii | Kowa Co., Ltd. | 2008 | — |
| 0 (this device) | K083387 | Modification to Kowa Nonmyd Alpha-Diii | Kowa Co., Ltd. | 2009 | — |
| +1 | K190056 | KOWA VK-2s | Kowa Co. Ltd. Chofu | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 12.8 · 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? (1)
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 |
|---|---|---|---|
| * | K082767 | Kowa Nonmyd Alpha-DiiiSummary page 2…device Predicate Device Manufacturer 510(k) No. Date Cleared KOWA nonmyd a-DIII (Type 1) Kowa Company, Ltd K082767 Oct 21,2008 Conclusion The KOWA nonmyd a-DIII is equipped with the same fundamental technology as the pr… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190056 | KOWA VK-2s | 2019 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K190056 (Kowa Co. Ltd. Chofu, 2019) has gone furthest, with 0 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. 2009, 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?
KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083387: Modification to Kowa Nonmyd Alpha-Diii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083387
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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