510(k) · Cleared
ClearedRetina Flowmeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heidelberg Engineering · HLI Ophthalmoscope, Ac-Powered
Cleared on Nov 14, 1994 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 14, 1994
- Review
- 91 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK943955 Retina FlowmeterHeidelberg Engineering · 1994
- Descendant · cites it directly · 4 of its ownK992606 Canon Laser Blood Flowmeter (CLBF) Model 100Canon USA, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK062416 Retinal Functional Imager (Rfi)Optical Imaging, Ltd. · 2006
- Descendant · 2 generations on · 1 of its ownK080180 Modification to Retinal Function Imager (Rfi)Optical Imaging, Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK193319 XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK153239 LSFG-NaviSoftcare Co., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K992606Canon Laser Blood Flowmeter (CLBF) Model 100Canon USA, Inc. · 2000 · cites it directly4descendants
- K062416Retinal Functional Imager (Rfi)Optical Imaging, Ltd. · 2006 · cites it directly3descendants
- K080180Modification to Retinal Function Imager (Rfi)Optical Imaging, Ltd. · 2008 · 2 generations on1descendant
- K193319XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc. · 2020 · 3 generations on0descendants
- K153239LSFG-NaviSoftcare Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943955 | Retina Flowmeter | Heidelberg Engineering | 1994 | — |
| +1 | K992606 | Canon Laser Blood Flowmeter (CLBF) Model 100 | Canon USA, Inc. | 2000 | — |
| +1 | K062416 | Retinal Functional Imager (Rfi) | Optical Imaging, Ltd. | 2006 | — |
| +2 | K080180 | Modification to Retinal Function Imager (Rfi) | Optical Imaging, Ltd. | 2008 | — |
| +3 | K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | 2020 | — |
| +2 | K153239 | LSFG-Navi | Softcare Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 HLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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, K992606 (Canon USA, Inc., 2000) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
MAUDE reports naming product code HLI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 36 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 4 | 112 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K943955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943955: Retina Flowmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943955
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026