510(k) · Cleared
ClearedKowa Nonmyd 7, Kowa Nonmyd a-D
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 10, 2005 as substantially equivalent to K014274 (Nidek, Inc., 2002) after a 14-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Nov 10, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941234 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 2 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 1 generation backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- This deviceK053026 Kowa Nonmyd 7, Kowa Nonmyd a-DKowa Co., Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK101628 Kowa Nonmyd WXKowa Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK191945 KOWA nonmyd 8Kowa Company, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK132987 Cobra Fundus CameraC.S.O. S.R.L. · 2014
- Descendant · cites it directly · 0 of its ownK062356 Kowa Nonmyd Alpha-DKowa Co., Ltd. · 2006
Most influential descendants
Showing 4 of 4 · See all- K101628Kowa Nonmyd WXKowa Co., Ltd. · 2011 · cites it directly2descendants
- K191945KOWA nonmyd 8Kowa Company, Ltd. · 2019 · 2 generations on0descendants
- K132987Cobra Fundus CameraC.S.O. S.R.L. · 2014 · 2 generations on0descendants
- K062356Kowa Nonmyd Alpha-DKowa Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −2 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −1 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| 0 (this device) | K053026 | Kowa Nonmyd 7, Kowa Nonmyd a-D | Kowa Co., Ltd. | 2005 | — |
| +1 | K101628 | Kowa Nonmyd WX | Kowa Co., Ltd. | 2011 | — |
| +2 | K191945 | KOWA nonmyd 8 | Kowa Company, Ltd. | 2019 | — |
| +2 | K132987 | Cobra Fundus Camera | C.S.O. S.R.L. | 2014 | — |
| +1 | K062356 | Kowa Nonmyd Alpha-D | Kowa Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000Summary page 3…Predicate Device Manufacturer 510(k) No. Date Cleared Nidek Non-Mydriatic Fundus Camera Model NM-I000 Nidek Incorporated K014274 Apr. 17, 2002 / () I no Led/ .h w w… | 2002 |
What descends from it? (4)
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 10 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101628 (Kowa Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K014274.
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 nonmyd series, non-mydriatic fundus camera, are intended for use with retina image capturing. The retina image can be stored to an external hard disk drive or transferred in other formats through memory card or serial interface depending on the output interface available for each device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053026: Kowa Nonmyd 7, Kowa Nonmyd a-D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053026
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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