510(k) · Cleared
ClearedCanon Laser Blood Flowmeter (CLBF) Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon USA, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Jun 21, 2000 as substantially equivalent to K943955 (Heidelberg Engineering, 1994) after a 323-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Jun 21, 2000
- Review
- 323 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943955 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK943955 Retina FlowmeterHeidelberg Engineering · 1994
- This deviceK992606 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K943955 | Retina Flowmeter | Heidelberg Engineering | 1994 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K943955 | Retina FlowmeterSummary page 1…gned Manufacturer: Heidelberg Engineering Gmbh Trade Name: Heidelberg Model Name: Retina Flowmeter Classification Name: FDA 510(k) #: HLI, Ophthalmoscope, AC-Powered K943955 Description Of Device: The Canon Laser Blood Flowmeter (CLBF) Model 100 allows for fundus observation with velocity measurement… | 1994 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062416 | Retinal Functional Imager (Rfi) | 2006 | 3 |
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?
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 | — |
What is it indicated for?
Canon Laser Blood Flowmeter CLBF model 100 is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF model 100, and it is intended to help doctors' reading of retinal images.
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/K992606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992606: Canon Laser Blood Flowmeter (CLBF) Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992606
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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