510(k) · Cleared
ClearedVista Digital Opthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eyequick.Llc · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jun 23, 2011 as substantially equivalent to K050271 (Kowa Co., Ltd., 2005) and 3 other predicates after a 303-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Jun 23, 2011
- Review
- 303 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K912891 (1991). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK912891 Heidelberg Retina TomographHeidelberg Engineering · 1991
- 1 generation backK974535 Discam Digital Imaging SystemMarcher Enterprises, Ltd. · 1998
- This deviceK102412 Vista Digital OpthalmoscopeEyequick.Llc · 2011
- Descendant · cites it directly · 1 of its ownK121405 PanopticWelch Allyn, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK223381 iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −2 | K912891 | Heidelberg Retina Tomograph | Heidelberg Engineering | 1991 | — |
| −1 | K974535 | Discam Digital Imaging System | Marcher Enterprises, Ltd. | 1998 | — |
| 0 (this device) | K102412 | Vista Digital Opthalmoscope | Eyequick.Llc | 2011 | — |
| +1 | K121405 | Panoptic | Welch Allyn, Inc. | 2012 | — |
| +2 | K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K050271 | Kowa Genesis-D Hand-Held Retinal CameraSummary page 1…Ophthalmic Camera, AC-Powered 21 CFR Part 886.1120 Class 11 Substantial equivalence claimed to: Kowa Genesis D3(K05027 1) Precision Optics Corporation, Inc. Digital Ophthalmoscope (K053425) Welch Allyn 11720 Ophthalmoscope (K95046 1) Discamn Digital… | 2005 |
| * | K053425 | Precision Optics Corporation Video Ophthalmoscope, Model 2500-VosSummary page 1…21 CFR Part 886.1120 Class 11 Substantial equivalence claimed to: Kowa Genesis D3(K05027 1) Precision Optics Corporation, Inc. Digital Ophthalmoscope (K053425) Welch Allyn 11720 Ophthalmoscope (K95046 1) Discamn Digital Imaging System (K97453 5) The EyeQuick Digital Ophthalmoscope is su… | 2006 |
| * | K950461 | Welch Allyn OphthalmoscopeSummary page 1…11 Substantial equivalence claimed to: Kowa Genesis D3(K05027 1) Precision Optics Corporation, Inc. Digital Ophthalmoscope (K053425) Welch Allyn 11720 Ophthalmoscope (K95046 1) Discamn Digital Imaging System (K97453 5) The EyeQuick Digital Ophthalmoscope is substantially equivalent to the predicate devi… | 1995 |
| * | K974535 | Discam Digital Imaging SystemSummary page 1…Kowa Genesis D3(K05027 1) Precision Optics Corporation, Inc. Digital Ophthalmoscope (K053425) Welch Allyn 11720 Ophthalmoscope (K95046 1) Discamn Digital Imaging System (K97453 5) The EyeQuick Digital Ophthalmoscope is substantially equivalent to the predicate devices with regard to intended use, operating… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121405 | Panoptic | 2012 | 1 |
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 20 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K121405 (Welch Allyn, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K050271.
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?
The EyeQuick Digital Ophthalmoscope Camera is intended for use in capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102412: Vista Digital Opthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102412
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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