510(k) · Cleared
ClearedOptomed Smartscope, Model M3-1 EY1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optomed OY · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Oct 1, 2009 as substantially equivalent to K003376 (Welch Allyn, Inc., 2001) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 2001. 22 later devices descend from it.
- Decided
- Oct 1, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003376 (2001). 2 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003376 Welch Allyn 11800 OpthalmoscopeWelch Allyn, Inc. · 2001
- This deviceK092056 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
- Descendant · 4 generations on · 2 of its ownK221329 Eyer Retinal Camera NM-STDPhelcom Technologies · 2023
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- 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
- K221329Eyer Retinal Camera NM-STDPhelcom Technologies · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn, Inc. | 2001 | — |
| 0 (this device) | 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 | — |
| +4 | K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 HKI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HKI device
- #1 K253176 TearViewscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003376 | Welch Allyn 11800 OpthalmoscopeSummary page 1…hthalmic, ac-powered (21 CFR 886.1120, Product code: HKI) Predicate devices: 1. WELCH ALLYN 11810 OPTHALMOSCOPE (510(k) number: K003376, Product code: HLI) 2. KOWA GENESIS-D hand-held retinal camera (510(k… | 2001 |
| * | K080681 | Kowa Genesis-DSummary page 1…, Product code: HLI) 2. KOWA GENESIS-D hand-held retinal camera (510(k) number: K080681, Product code: HKI) Device description, Intended use & Effectiveness: Optomed Smartscope M3-1 EY1 is a hand-held digital ophth… | 2008 |
What descends from it? (22)
See all 222 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?
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Optomed Smartscope M3-1 EY1 digital ophthalmoscope is intended to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092056: Optomed Smartscope, Model M3-1 EY1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092056
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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