510(k) · Cleared
ClearedLSFG-Navi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Softcare Co., Ltd. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on May 12, 2016 as substantially equivalent to K062416 (Optical Imaging, Ltd., 2006) after a 185-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- May 12, 2016
- Review
- 185 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. No later device cites it as a predicate yet.
- 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 deviceK153239 LSFG-NaviSoftcare Co., Ltd. · 2016
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) | K153239 | LSFG-Navi | Softcare Co., Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K062416 | Retinal Functional Imager (Rfi)Summary page 6…tantial Equivalent: The Laser Speckle Flowgraphy LSFG-NAVI is considered to be substantially equivalent to the predicate device below: Retinal Functional Imager (K062416) - Optical Imaging, Ltd. The comparison of the technological characteristics between LSFG-NAVI and the Retinal Functional Image… | 2006 |
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 22 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 5 ancestors has a recall.
- 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. 2016, 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 LSFG-NAVI system is intended to capture and display the blood flow distribution in the human retina in real time, and to monitor the blood flow in retinal vessels for their quantitative evaluation.
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/K153239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153239: LSFG-Navi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153239
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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