510(k) · Cleared
ClearedXyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasoptic Medical, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jun 1, 2020 as substantially equivalent to K080180 (Optical Imaging, Ltd., 2008) after a 182-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jun 1, 2020
- Review
- 182 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943955 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK943955 Retina FlowmeterHeidelberg Engineering · 1994
- 3 generations backK992606 Canon Laser Blood Flowmeter (CLBF) Model 100Canon USA, Inc. · 2000
- 2 generations backK062416 Retinal Functional Imager (Rfi)Optical Imaging, Ltd. · 2006
- 1 generation backK080180 Modification to Retinal Function Imager (Rfi)Optical Imaging, Ltd. · 2008
- This deviceK193319 XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943955 | Retina Flowmeter | Heidelberg Engineering | 1994 | — |
| −3 | K992606 | Canon Laser Blood Flowmeter (CLBF) Model 100 | Canon USA, Inc. | 2000 | — |
| −2 | K062416 | Retinal Functional Imager (Rfi) | Optical Imaging, Ltd. | 2006 | — |
| −1 | K080180 | Modification to Retinal Function Imager (Rfi) | Optical Imaging, Ltd. | 2008 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K080180 | Modification to Retinal Function Imager (Rfi)Summary page 4…ion Number 21 CFR 886.1120 Regulatory Classification II III. Predicate Device Predicate Device Retinal Functional Imager 3000 (RFI 3000), K080180 Reference Device Laser Speckle Flowgraphy LSFG-NAVI, K153239 IV. Device Description The XyCAM™ RI System (or Xy… | 2008 |
| † | K153239 | LSFG-Navi | 2016 |
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 26 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 6 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. 2020, 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 XyCAM RI System is intended to capture, store, and display images of dynamic blood flow changes in the human retina, and to provide quantitative outputs of relative blood flow information.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193319 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193319: XyCAM RI, XyCAM RI System, XyCAM Retinal 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/K193319
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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