510(k) · Cleared
ClearedKOWA DR-1a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kowa Company, Ltd. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jun 4, 2019 as substantially equivalent to K091935 (Tearscience, Inc., 2009) after a 90-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jun 4, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913929 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK913929 DFC-1024 & DFC-512 Digital Imaging SystemOphthalmic Imaging Systems · 1991 · Recalled
- 3 generations backK971685 Imagescape Digital Retinal Image SystemTomey Corporation USA · 1997
- 2 generations backK980295 Ophthavision Imaging SystemMrp Group, Inc. · 1998
- 1 generation backK091935 Lipiview Ocular Surface InterferometerTearscience, Inc. · 2009
- This deviceK190573 KOWA DR-1aKowa Company, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913929 | DFC-1024 & DFC-512 Digital Imaging System | Ophthalmic Imaging Systems | 1991 | 5 |
| −3 | K971685 | Imagescape Digital Retinal Image System | Tomey Corporation USA | 1997 | — |
| −2 | K980295 | Ophthavision Imaging System | Mrp Group, Inc. | 1998 | — |
| −1 | K091935 | Lipiview Ocular Surface Interferometer | Tearscience, Inc. | 2009 | — |
| 0 (this device) | K190573 | KOWA DR-1a | Kowa Company, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 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.
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 9.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K091935.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by
physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film,
which can be visually monitored and photographically documented.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190573 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190573: KOWA DR-1a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190573
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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