510(k) · Cleared
ClearedVantage Indirect Ophthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler Instruments, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on May 23, 2006 as substantially equivalent to K942104 (Keeler Instruments, Inc., 1994) after a 57-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- May 23, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942104 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK942104 Keeler Vantage Indirect OphthalmoscopeKeeler Instruments, Inc. · 1994
- This deviceK060822 Vantage Indirect OphthalmoscopeKeeler Instruments, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK123316 Heine Omega 500Heine Optotechnik GmbH & Co. KG · 2013
- Descendant · 2 generations on · 0 of its ownK142837 Heine Sigma 250 & Heine Sigma 250 M2Heine Optotechnik GmbH & Co. KG · 2015
- Descendant · 2 generations on · 0 of its ownK141638 Propper Insight Binocular Indirect OphthalmosopePropper Manufacturing Co., Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K123316Heine Omega 500Heine Optotechnik GmbH & Co. KG · 2013 · cites it directly2descendants
- K142837Heine Sigma 250 & Heine Sigma 250 M2Heine Optotechnik GmbH & Co. KG · 2015 · 2 generations on0descendants
- K141638Propper Insight Binocular Indirect OphthalmosopePropper Manufacturing Co., Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942104 | Keeler Vantage Indirect Ophthalmoscope | Keeler Instruments, Inc. | 1994 | — |
| 0 (this device) | K060822 | Vantage Indirect Ophthalmoscope | Keeler Instruments, Inc. | 2006 | — |
| +1 | K123316 | Heine Omega 500 | Heine Optotechnik GmbH & Co. KG | 2013 | — |
| +2 | K142837 | Heine Sigma 250 & Heine Sigma 250 M2 | Heine Optotechnik GmbH & Co. KG | 2015 | — |
| +2 | K141638 | Propper Insight Binocular Indirect Ophthalmosope | Propper Manufacturing Co., Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K942104 | Keeler Vantage Indirect OphthalmoscopeSummary page 1…The unit has adjustable illumination levels and is powered by the same power sources to that used on the Vantage (Re: 5 10(k) K942 104). To improve the ease of use of the instrument, the Vantage Plus combines the Aperture… | 1994 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123316 | Heine Omega 500 | 2013 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K123316 (Heine Optotechnik GmbH & Co. KG, 2013) has gone furthest, with 2 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 | — |
What is it indicated for?
The Keeler Vantage Plus Indirect Ophthalmoscope is intended to be used to examine the Cornea, aqueous, lens,
vitreous and retina of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060822: Vantage Indirect Ophthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060822
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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