510(k) · Cleared
ClearedFundus Autoimager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visual Pathways, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Nov 7, 2002 as substantially equivalent to K011877 (Carl Zeiss Jena GmbH, 2001) and 1 other predicate after a 234-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Nov 7, 2002
- Review
- 234 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K870039 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870039 Imagenet Digital Ophthalmic Imaging SystemPar Microsystems Corp. · 1987
- This deviceK020888 Fundus AutoimagerVisual Pathways, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870039 | Imagenet Digital Ophthalmic Imaging System | Par Microsystems Corp. | 1987 | — |
| 0 (this device) | K020888 | Fundus Autoimager | Visual Pathways, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K011877 | FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus… | 2001 |
| * | K870039 | Imagenet Digital Ophthalmic Imaging SystemSummary page 1…s Jena GmbH FF45O(p1us) VI SUPAC KO1 1877 Topcon Medical Systems ImageNet Digital Ophthalmic K870039 Imaging System… | 1987 |
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?
- None of the 2 ancestors has a recall.
- 7 other devices also cite its predicate K011877.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Fundus AutoImagerTM is an automated ocular fimdus imaging device that allows for the rapid capture, storage, manipulation and transmission of images of the eye, especially the retina area, as an 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/K020888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020888: Fundus Autoimager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020888
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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