510(k) · Cleared
ClearedHeine Omega 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heine Optotechnik GmbH & Co. KG · HLI Ophthalmoscope, Ac-Powered
Cleared on Feb 26, 2013 as substantially equivalent to K060822 (Keeler Instruments, Inc., 2006) and 2 other predicates after a 124-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 26, 2013
- Review
- 124 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942104 (1994). 4 ancestors in all, the oldest K930023 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942104 Keeler Vantage Indirect OphthalmoscopeKeeler Instruments, Inc. · 1994
- 1 generation backK060822 Vantage Indirect OphthalmoscopeKeeler Instruments, Inc. · 2006
- This deviceK123316 Heine Omega 500Heine Optotechnik GmbH & Co. KG · 2013
- Descendant · cites it directly · 0 of its ownK142837 Heine Sigma 250 & Heine Sigma 250 M2Heine Optotechnik GmbH & Co. KG · 2015
- Descendant · cites it directly · 0 of its ownK141638 Propper Insight Binocular Indirect OphthalmosopePropper Manufacturing Co., Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942104 | Keeler Vantage Indirect Ophthalmoscope | Keeler Instruments, Inc. | 1994 | — |
| −1 | K060822 | Vantage Indirect Ophthalmoscope | Keeler Instruments, Inc. | 2006 | — |
| 0 (this device) | K123316 | Heine Omega 500 | Heine Optotechnik GmbH & Co. KG | 2013 | — |
| +1 | K142837 | Heine Sigma 250 & Heine Sigma 250 M2 | Heine Optotechnik GmbH & Co. KG | 2015 | — |
| +1 | K141638 | Propper Insight Binocular Indirect Ophthalmosope | Propper Manufacturing Co., Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K060822 | Vantage Indirect OphthalmoscopeSummary page 2…ces: Device Trade Name: Vantage Plus Binocular Indirect Ophthalmoscope Applicant: Keeler Instruments Inc. 510 (k) No.: K060822 Device Trade Name: NEITZ Binocular Indirect Ophthalmoscope 10-A Applicant: NEITZ Instruments Com… | 2006 |
| * | K942712 | Neitz Halogen Binocular Indirect Ophthalmoscope IO-aSummary page 2…Device Trade Name: NEITZ Binocular Indirect Ophthalmoscope 10-A Applicant: NEITZ Instruments Company, Ltd. 510 (k) No.: K942712 Device Trade Name: Model #12000 Binocular Indirect Ophthalmoscope Applicant: Welch Allyn, Inc. 5… | 1994 |
| * | K930023 | Model #12000 Binocular Inderect OphthalmoscopeSummary page 2…K942712 Device Trade Name: Model #12000 Binocular Indirect Ophthalmoscope Applicant: Welch Allyn, Inc. 51 0(k) No.: K930023 The HEINE OMEGA 500 is considered substantial equivalent to the Vantage Plus Binocular Indirect Ophthalmoscope (K060822), NEI… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K142837 (Heine Optotechnik GmbH & Co. KG, 2015) has gone furthest, with 0 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. 2013, this device’s year, is highlighted.
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 indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
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/K123316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123316: Heine Omega 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123316
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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