510(k) · Cleared
ClearedOpto Global Digital Fundus Camera System Model Ads 1.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opto Global, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jan 24, 2006 as substantially equivalent to K021787 (Carl Zeiss Ophthalmic Systems, Inc., 2002) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Jan 24, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011877 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011877 FF450 Plus Fundus Camera and Visupac Digital Image Archiving System…Carl Zeiss Jena GmbH · 2001
- 1 generation backK021787 VisucamCarl Zeiss Ophthalmic Systems, Inc. · 2002
- This deviceK053044 Opto Global Digital Fundus Camera System Model Ads 1.5Opto Global, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK091064 Navilas Laser SystemOd-Os GmbH · 2009
- Descendant · 2 generations on · 2 of its ownK141851 Navilas Laser SystemOd-Os GmbH · 2015
- Descendant · 3 generations on · 1 of its ownK162191 NAVILAS Laser SystemOd-Os GmbH · 2016
- Descendant · 4 generations on · 0 of its ownK251772 Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
Most influential descendants
Showing 4 of 4 · See all- K091064Navilas Laser SystemOd-Os GmbH · 2009 · cites it directly3descendants
- K141851Navilas Laser SystemOd-Os GmbH · 2015 · 2 generations on2descendants
- K162191NAVILAS Laser SystemOd-Os GmbH · 2016 · 3 generations on1descendant
- K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011877 | FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450… | Carl Zeiss Jena GmbH | 2001 | — |
| −1 | K021787 | Visucam | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| 0 (this device) | K053044 | Opto Global Digital Fundus Camera System Model Ads 1.5 | Opto Global, Inc. | 2006 | — |
| +1 | K091064 | Navilas Laser System | Od-Os GmbH | 2009 | — |
| +2 | K141851 | Navilas Laser System | Od-Os GmbH | 2015 | — |
| +3 | K162191 | NAVILAS Laser System | Od-Os GmbH | 2016 | — |
| +4 | K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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 12.8 · 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? (4)
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 |
|---|---|---|---|
| * | K021787 | VisucamSummary page 1…Date Prepared: 20 August 2005 Predicate Devices Visucam Carl Zeiss Ophthalmic Systems Inc K021787 FF450 plus Visupac System Carl Zeiss Jena CmbH K011877 Imagenet Digital Ophthalmic Imaging* Topcon… | 2002 |
| * | K011877 | FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus…Summary page 1…vices Visucam Carl Zeiss Ophthalmic Systems Inc K021787 FF450 plus Visupac System Carl Zeiss Jena CmbH K011877 Imagenet Digital Ophthalmic Imaging* Topcon Corp *(Sold in the U.S. for years) Can… | 2001 |
| * | — | Imagenet Digital Ophthalmic Imaging Named without a submission number | |
| * | — | 50 EX Fundus camera Named without a submission number |
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 |
|---|---|---|---|
| K091064 | Navilas Laser System | 2009 | 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091064 (Od-Os GmbH, 2009) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K021787.
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 OPTO Global Digital Fundus Camera System Model ADS 1.5 is intended to be used to capture, archive, recall and display black and white, and color images of the retina, as well as surrounding areas, to aid in the diagnosis and monitoring of diseases of the eye that may be viewed and photographed non-invasively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053044: Opto Global Digital Fundus Camera System Model Ads 1.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053044
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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