510(k) · Cleared
ClearedEyecap Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clement Clarke Intl., Ltd. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on May 4, 2000 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- May 4, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK000368 Eyecap Imaging SystemClement Clarke Intl., Ltd. · 2000
- Descendant · cites it directly · 5 of its ownK110129 Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC · 2011
- Descendant · 2 generations on · 4 of its ownK133476 Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG · 2014
- Descendant · 3 generations on · 1 of its ownK162684 SL 220Carl Zeiss Meditec, AG · 2017
- Descendant · 4 generations on · 0 of its ownK253834 Visuref 600Carl Zeiss Vision GmbH · 2026
- Descendant · 3 generations on · 0 of its ownK163564 Slit Lamp SL-2000Nidek Co., Ltd. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110129Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC · 2011 · cites it directly5descendants
- K133476Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG · 2014 · 2 generations on4descendants
- K162684SL 220Carl Zeiss Meditec, AG · 2017 · 3 generations on1descendant
- K253834Visuref 600Carl Zeiss Vision GmbH · 2026 · 4 generations on0descendants
- K163564Slit Lamp SL-2000Nidek Co., Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000368 | Eyecap Imaging System | Clement Clarke Intl., Ltd. | 2000 | — |
| +1 | K110129 | Righton Zoom Slit Lamp Microscope with Photo Option | Rightmedical Products, LLC | 2011 | — |
| +2 | K133476 | Slit Lamps with SL Cam 5.0 Digital Imaging Solution | Carl Zeiss Meditec, AG | 2014 | — |
| +3 | K162684 | SL 220 | Carl Zeiss Meditec, AG | 2017 | — |
| +4 | K253834 | Visuref 600 | Carl Zeiss Vision GmbH | 2026 | — |
| +3 | K163564 | Slit Lamp SL-2000 | Nidek Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
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?
- Of its descendants, K110129 (Rightmedical Products, LLC, 2011) has gone furthest, with 5 descendants of its own.
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 EyeCap Imaging System is used by Health Professionals to capture, store and manage
output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K000368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000368: Eyecap Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000368
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026