510(k) · Cleared
ClearedWelch Allyn 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 Apr 4, 1995 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 4, 1995
- Review
- 60 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK950461 Welch Allyn OphthalmoscopeWelch Allyn, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK102412 Vista Digital OpthalmoscopeEyequick.Llc · 2011
- Descendant · 2 generations on · 1 of its ownK121405 PanopticWelch Allyn, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK223381 iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK131939 Amico DH-W35 Ophthalmoscope SeriesAmico Diagnostic Incorporated · 2014
Most influential descendants
Showing 4 of 4 · See all- K102412Vista Digital OpthalmoscopeEyequick.Llc · 2011 · cites it directly2descendants
- K121405PanopticWelch Allyn, Inc. · 2012 · 2 generations on1descendant
- K223381iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023 · 3 generations on0descendants
- K131939Amico DH-W35 Ophthalmoscope SeriesAmico Diagnostic Incorporated · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950461 | Welch Allyn Ophthalmoscope | Welch Allyn, Inc. | 1995 | — |
| +1 | K102412 | Vista Digital Opthalmoscope | Eyequick.Llc | 2011 | — |
| +2 | K121405 | Panoptic | Welch Allyn, Inc. | 2012 | — |
| +3 | K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023 | — |
| +1 | K131939 | Amico DH-W35 Ophthalmoscope Series | Amico Diagnostic Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 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? (4)
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?
- Of its descendants, K102412 (Eyequick.Llc, 2011) 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/K950461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950461: Welch Allyn Ophthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950461
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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