510(k) · Cleared
ClearedKowa Nonmyd WX
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 26, 2011 as substantially equivalent to K053026 (Kowa Co., Ltd., 2005) and 1 other predicate after a 230-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 26, 2011
- Review
- 230 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K941234 (1995). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 3 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 2 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 1 generation backK053026 Kowa Nonmyd 7, Kowa Nonmyd a-DKowa Co., Ltd. · 2005
- This deviceK101628 Kowa Nonmyd WXKowa Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK191945 KOWA nonmyd 8Kowa Company, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK132987 Cobra Fundus CameraC.S.O. S.R.L. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −3 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −2 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −1 | K053026 | Kowa Nonmyd 7, Kowa Nonmyd a-D | Kowa Co., Ltd. | 2005 | — |
| 0 (this device) | K101628 | Kowa Nonmyd WX | Kowa Co., Ltd. | 2011 | — |
| +1 | K191945 | KOWA nonmyd 8 | Kowa Company, Ltd. | 2019 | — |
| +1 | K132987 | Cobra Fundus Camera | C.S.O. S.R.L. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 12.7 · 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 |
|---|---|---|---|
| * | K053026 | Kowa Nonmyd 7, Kowa Nonmyd a-DSummary page 1…I, NFJ Identification of predicate devices: Kowa Company believes that this device is substantially equivalent to: KOWA nonmydl 7 manufactured by Kowa, 51 0(k)# K053026, Nidek 3-DX/3-DXF Stereo Disc/Fundus Cameras maiiufactured by Nidek,… | 2005 |
| * | K973533 | Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF)Summary page 1…51 0(k)# K053026, Nidek 3-DX/3-DXF Stereo Disc/Fundus Cameras maiiufactured by Nidek, 5 10(k)9l K973 533. Device description: The KOWA nonmyd WX is a retinal camera without mydriatic. Plane retinal image capturing function, that is n… | 1997 |
What descends from it? (2)
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 16 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K191945 (Kowa Company, Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K053026.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retinal image can be stored to anl image filing device through serial interface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101628: Kowa Nonmyd WX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101628
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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