510(k) · Cleared
ClearedWelch Allyn 11800 Opthalmoscope
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 Jan 25, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.
- Decided
- Jan 25, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 3 citing it directly.
- This deviceK003376 Welch Allyn 11800 OpthalmoscopeWelch Allyn, Inc. · 2001
- Descendant · cites it directly · 22 of its ownK092056 Optomed Smartscope, Model M3-1 EY1Optomed OY · 2009
- Descendant · cites it directly · 20 of its ownK110986 Optomed Smartscope M5 EY3 and M5 ES1Optomed OY · 2011
- Descendant · 2 generations on · 9 of its ownK132186 Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope…Optomed OY · 2013
- Descendant · 2 generations on · 6 of its ownK120982 Digital Eye-Fundus CameraMedimaging Integrated Solutions, Inc. (Miis) · 2012
- Descendant · 3 generations on · 4 of its ownK180378 Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior…Optomed OY · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K092056Optomed Smartscope, Model M3-1 EY1Optomed OY · 2009 · cites it directly22descendants
- K110986Optomed Smartscope M5 EY3 and M5 ES1Optomed OY · 2011 · cites it directly20descendants
- K132186Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2Optomed OY · 2013 · 2 generations on9descendants
- K120982Digital Eye-Fundus CameraMedimaging Integrated Solutions, Inc. (Miis) · 2012 · 2 generations on6descendants
- K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleOptomed OY · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn, Inc. | 2001 | — |
| +1 | K092056 | Optomed Smartscope, Model M3-1 EY1 | Optomed OY | 2009 | — |
| +1 | K110986 | Optomed Smartscope M5 EY3 and M5 ES1 | Optomed OY | 2011 | — |
| +2 | K132186 | Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2 | Optomed OY | 2013 | — |
| +2 | K120982 | Digital Eye-Fundus Camera | Medimaging Integrated Solutions, Inc. (Miis) | 2012 | — |
| +3 | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Optomed OY | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (23)
See all 233 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?
- Of its descendants, K092056 (Optomed OY, 2009) has gone furthest, with 22 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/K003376 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003376: Welch Allyn 11800 Opthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003376
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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