510(k) · Cleared
ClearedModel #12000 Binocular Inderect Ophthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Jun 21, 1993 after a 167-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 21, 1993
- Review
- 167 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK930023 Model #12000 Binocular Inderect OphthalmoscopeWelch Allyn, Inc. · 1993
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K930023 | Model #12000 Binocular Inderect Ophthalmoscope | Welch Allyn, Inc. | 1993 | — |
| +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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- 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 | — |
https://510kreport.com/device/K930023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930023: Model #12000 Binocular Inderect Ophthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930023
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026