510(k) · Cleared
ClearedOptomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2
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 Dec 18, 2013 as substantially equivalent to K110986 (Optomed OY, 2011) after a 156-day review. Its family tree reaches back 3 generations to 2001. 9 later devices descend from it.
- Decided
- Dec 18, 2013
- Review
- 156 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003376 (2001). 4 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK003376 Welch Allyn 11800 OpthalmoscopeWelch Allyn, Inc. · 2001
- 2 generations backK092056 Optomed Smartscope, Model M3-1 EY1Optomed OY · 2009
- 1 generation backK110986 Optomed Smartscope M5 EY3 and M5 ES1Optomed OY · 2011
- This deviceK132186 Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope…Optomed OY · 2013
- Descendant · cites it directly · 4 of its ownK180378 Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior…Optomed OY · 2018
- Descendant · 2 generations on · 2 of its ownK221329 Eyer Retinal Camera NM-STDPhelcom Technologies · 2023
- Descendant · cites it directly · 1 of its ownK152869 LipiView II Ocular Surface InterferometerTearscience, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK251353 Eyer 2Phelcom Technologies · 2026
- Descendant · 2 generations on · 0 of its ownK252120 Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleOptomed OY · 2018 · cites it directly4descendants
- K221329Eyer Retinal Camera NM-STDPhelcom Technologies · 2023 · 2 generations on2descendants
- K152869LipiView II Ocular Surface InterferometerTearscience, Inc. · 2016 · cites it directly1descendant
- K251353Eyer 2Phelcom Technologies · 2026 · 2 generations on0descendants
- K252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn, Inc. | 2001 | — |
| −2 | K092056 | Optomed Smartscope, Model M3-1 EY1 | Optomed OY | 2009 | — |
| −1 | K110986 | Optomed Smartscope M5 EY3 and M5 ES1 | Optomed OY | 2011 | — |
| 0 (this device) | K132186 | Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2 | Optomed OY | 2013 | — |
| +1 | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Optomed OY | 2018 | — |
| +2 | K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | 2023 | — |
| +1 | K152869 | LipiView II Ocular Surface Interferometer | Tearscience, Inc. | 2016 | — |
| +2 | K251353 | Eyer 2 | Phelcom Technologies | 2026 | — |
| +2 | K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | 2025 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K110986 | Optomed Smartscope M5 EY3 and M5 ES1Summary page 1…ode: HKI) Predicate device: Optomed Smartscope MS with optics modules EY3 with ESi (510(k) number: K110986, Product code: -IKI) Indlicatians'for Use: Optomed Smartscope MS digital camerawith EY4 optics module is… | 2011 |
What descends from it? (9)
4 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 12 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K180378 (Optomed OY, 2018) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K110986.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, 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 · 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 M5 digital camera with EY4 optics module is Intended to capture digital images and video of the fundlus of the human eye.
Optomed Smartscope MVS with optics module ESZ IsIntended to capture images and video of the surface of the human eye and surrounding areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132186 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132186
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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