510(k) · Cleared
ClearedOptina-4C (MHRC-C1N)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optina Diagnostics, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Sep 4, 2025 as substantially equivalent to K231230 (Optina Diagnostics, Inc., 2023) after a 175-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Sep 4, 2025
- Review
- 175 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K941234 (1995). 13 ancestors in all, the oldest K946058 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 7 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 6 generations backK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
- 5 generations backK080883 CR-1Canon, Inc. · 2008
- 4 generations backK092565 Digital Retinal Camera CX-1Canon Components, Inc. · 2010
- 3 generations backK112330 Kowa VX-20Kowa Co., Ltd. · 2012
- 2 generations backK200254 Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics · 2020
- 1 generation backK231230 Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. · 2023
- This deviceK250770 Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −7 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −6 | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-Dgi | Canon USA, Inc. | 2003 | — |
| −5 | K080883 | CR-1 | Canon, Inc. | 2008 | — |
| −4 | K092565 | Digital Retinal Camera CX-1 | Canon Components, Inc. | 2010 | — |
| −3 | K112330 | Kowa VX-20 | Kowa Co., Ltd. | 2012 | — |
| −2 | K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | 2020 | — |
| −1 | K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2023 | — |
| 0 (this device) | K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K231230 | Optina-4C (MHRC-C1N)Summary page 5…Product Code HKI) DEVICE Class II CLASSIFICATION MHRC-C1N (K231230) PREDICATE DEVICES Camera, Ophthalmic, Ac-Powered (21 CFR 886.1120,… | 2023 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 13 ancestors has a recall.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Optina-4C TM is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying, storing, and transferring images of the retina. The Optina-4C is indicated for the viewing of the posterior segment of the eye at multiple wavelengths (colors) under mydriatic conditions.
Images are intended to aid clinicians in the detection, diagnosis, and management of ocular health and disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250770: Optina-4C (MHRC-C1N).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250770
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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