510(k) · Cleared
ClearedModification to Retinal Function Imager (Rfi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optical Imaging, Ltd. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jun 11, 2008 as substantially equivalent to K062416 (Optical Imaging, Ltd., 2006) after a 139-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jun 11, 2008
- Review
- 139 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943955 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK943955 Retina FlowmeterHeidelberg Engineering · 1994
- 2 generations backK992606 Canon Laser Blood Flowmeter (CLBF) Model 100Canon USA, Inc. · 2000
- 1 generation backK062416 Retinal Functional Imager (Rfi)Optical Imaging, Ltd. · 2006
- This deviceK080180 Modification to Retinal Function Imager (Rfi)Optical Imaging, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK193319 XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193319XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943955 | Retina Flowmeter | Heidelberg Engineering | 1994 | — |
| −2 | K992606 | Canon Laser Blood Flowmeter (CLBF) Model 100 | Canon USA, Inc. | 2000 | — |
| −1 | K062416 | Retinal Functional Imager (Rfi) | Optical Imaging, Ltd. | 2006 | — |
| 0 (this device) | K080180 | Modification to Retinal Function Imager (Rfi) | Optical Imaging, Ltd. | 2008 | — |
| +1 | K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K062416 | Retinal Functional Imager (Rfi)Summary page 2…Page 1 of 5 iGjptical Imaging Ltd. FDA Special 5 10(k) Predicate device: Retinal Functional Imager (RFI) - cleared under 510(k) no. K062416 Description of Modification The Retinal Functional Imager (RFI), cleared under 510(k) number K062416, was based o… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | 2020 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K193319 (Vasoptic Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062416.
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 | — |
What is it indicated for?
The Retinal Functional Imager (RFI) is intended to observe,
capture, display, and store images of patients' fundus (retina)
under mydriatic conditions to aid in diagnosing or monitoring
diseases of the eye that may be observed and photographed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080180: Modification to Retinal Function Imager (Rfi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080180
Report an extraction error
Are you the manufacturer?
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