510(k) · Cleared
ClearedKowa Genesis-D Hand-Held Retinal Camera
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 3, 2005 after a 272-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Nov 3, 2005
- Review
- 272 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK050271 Kowa Genesis-D Hand-Held Retinal CameraKowa Co., Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK102412 Vista Digital OpthalmoscopeEyequick.Llc · 2011
- Descendant · 2 generations on · 1 of its ownK121405 PanopticWelch Allyn, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK091098 Kowagenesis-DFKowa Co., Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK223381 iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK201325 Optomed Smartscope M5 with Optomed Smartscope FAOptomed Oyj · 2020
Most influential descendants
Showing 5 of 5 · See all- K102412Vista Digital OpthalmoscopeEyequick.Llc · 2011 · cites it directly2descendants
- K121405PanopticWelch Allyn, Inc. · 2012 · 2 generations on1descendant
- K091098Kowagenesis-DFKowa Co., Ltd. · 2009 · cites it directly1descendant
- K223381iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023 · 3 generations on0descendants
- K201325Optomed Smartscope M5 with Optomed Smartscope FAOptomed Oyj · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050271 | Kowa Genesis-D Hand-Held Retinal Camera | Kowa Co., Ltd. | 2005 | — |
| +1 | K102412 | Vista Digital Opthalmoscope | Eyequick.Llc | 2011 | — |
| +2 | K121405 | Panoptic | Welch Allyn, Inc. | 2012 | — |
| +1 | K091098 | Kowagenesis-DF | Kowa Co., Ltd. | 2009 | — |
| +3 | K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023 | — |
| +2 | K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | — | Kowa Genesis Named without a submission number | |
| * | — | Nidek Handy NM-100 Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K102412 (Eyequick.Llc, 2011) 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.
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 hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050271: Kowa Genesis-D Hand-Held Retinal Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050271
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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