510(k) · Cleared
Recalled · Class II · 2020KOWA VK-2s
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kowa Co. Ltd. Chofu · NFJ System, Image Management, Ophthalmic
Cleared on Feb 12, 2019 as substantially equivalent to K173689 (Canon Inc. -Medical Equipment Group, 2018) and 1 other predicate after a 32-day review. Its family tree reaches back 2 generations to 2008. It has been recalled once.
- Decided
- Feb 12, 2019
- Review
- 32 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K082767 (2008). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082767 | Kowa Nonmyd Alpha-Diii | Kowa Co., Ltd. | 2008 | — |
| −1 | K083387 | Modification to Kowa Nonmyd Alpha-Diii | Kowa Co., Ltd. | 2009 | — |
| 0 (this device) | K190056 | KOWA VK-2s | Kowa Co. Ltd. Chofu | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 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 NFJ? 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 NFJ device
- #1 K260694 Zeiss Clinic 360score 15.0 · 12 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 |
|---|---|---|---|
| * | K173689 | Ophthalmic Software Platform RXSummary page 5…K190056 Primary: The VK-2s is substantially equivalent to the image management software system Canon Ophthalmic Software Platform RX cleared in K173689. As explained in more detail below, the Canon Ophthalmic Software Platform RX and the VK-2s software both have the same ind… | 2018 |
| * | K083387 | Modification to Kowa Nonmyd Alpha-DiiiSummary page 5…tion, and similar technological characteristics. Secondary: The VK-2s is substantially equivalent to the KOWA portable VK-2 in the KOWA nonmyd α-DIII cleared in K083387. The KOWA portable VK-2 and the VK- 2s software both have the same intended use, similar principles of operation, and simil… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2020 | Class II | Z-0636-2021 | Under Investigation by firm | It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K173689.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NFJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NFJ
85in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFJ
2in 2022
MAUDE reports naming product code NFJ, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 67 | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 73 | 0 | 6 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 87 | 1 | 2 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 5 | 175 | 0 | 4 |
| 2018 | 7 | 84 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 5 | 116 | 2 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 284 | 1 | 2 |
| 2023 | 4 | 85 | 0 | 0 |
| 2024 | 2 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190056: KOWA VK-2s.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190056
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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