510(k) · Cleared
Recalled · Class II · 2014Retcam 3 Ophthalmic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarity Medical Systems · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Nov 5, 2008 after a 127-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 5, 2008
- Review
- 127 days
- Class
- Class II
- Product code
- HKI
- Recalls
- 3
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK081858 Retcam 3 Ophthalmic Imaging SystemClarity Medical Systems · 2008
- Descendant · cites it directly · 8 of its ownK083771 Retcam Portable Ophthalmic Imaging System, Model RCPClarity Medical Systems · 2009
- Descendant · cites it directly · 7 of its ownK090326 Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic…Clarity Medical Systems · 2009 · Recalled
- Descendant · cites it directly · 4 of its ownK102859 Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK170527 Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical · 2017
- Descendant · 2 generations on · 1 of its ownK183059 3nethra neoForus Health Pvt.Ltd · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K083771Retcam Portable Ophthalmic Imaging System, Model RCPClarity Medical Systems · 2009 · cites it directly8descendants
- K090326Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging SystemsClarity Medical Systems · 2009 · cites it directly7descendants
- K102859Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 2011 · cites it directly4descendants
- K170527Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical · 2017 · 2 generations on3descendants
- K1830593nethra neoForus Health Pvt.Ltd · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081858 | Retcam 3 Ophthalmic Imaging System | Clarity Medical Systems | 2008 | — |
| +1 | K083771 | Retcam Portable Ophthalmic Imaging System, Model RCP | Clarity Medical Systems | 2009 | — |
| +1 | K090326 | Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems | Clarity Medical Systems | 2009 | 2 |
| +1 | K102859 | Retcam 3 Opthalmic Imaging System | Clarity Medical Systems | 2011 | 2 |
| +2 | K170527 | Phoenix Clinical ICON | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017 | — |
| +2 | K183059 | 3nethra neo | Forus Health Pvt.Ltd | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2014 | Class II | Z-1265-2014 | Nonconforming Material/Component | One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module. |
| Jan 24, 2014 | Class II | Z-1154-2014 | Software Manufacturing/Software Deployment | Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly. |
| Feb 2, 2012 | Not classified | Z-1099-2012 | Software design | Still images extracted from video recordings may be mislabeled as to right and left eye. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083771 (Clarity Medical Systems, 2009) has gone furthest, with 8 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. 2008, 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 | — |
https://510kreport.com/device/K081858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081858: Retcam 3 Ophthalmic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081858
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026