510(k) · Cleared
ClearedEyer 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phelcom Technologies · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jan 16, 2026 as substantially equivalent to K221329 (Phelcom Technologies, 2023) and 1 other predicate after a 261-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jan 16, 2026
- Review
- 261 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003376 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK003376 Welch Allyn 11800 OpthalmoscopeWelch Allyn, Inc. · 2001
- 5 generations backK092056 Optomed Smartscope, Model M3-1 EY1Optomed OY · 2009
- 4 generations backK110986 Optomed Smartscope M5 EY3 and M5 ES1Optomed OY · 2011
- 3 generations backK132186 Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope…Optomed OY · 2013
- 2 generations backK180378 Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior…Optomed OY · 2018
- 1 generation backK221329 Eyer Retinal Camera NM-STDPhelcom Technologies · 2023
- This deviceK251353 Eyer 2Phelcom Technologies · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn, Inc. | 2001 | — |
| −5 | K092056 | Optomed Smartscope, Model M3-1 EY1 | Optomed OY | 2009 | — |
| −4 | K110986 | Optomed Smartscope M5 EY3 and M5 ES1 | Optomed OY | 2011 | — |
| −3 | K132186 | Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2 | Optomed OY | 2013 | — |
| −2 | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Optomed OY | 2018 | — |
| −1 | K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | 2023 | — |
| 0 (this device) | K251353 | Eyer 2 | Phelcom Technologies | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K221329 | Eyer Retinal Camera NM-STDSummary page 5…yer Retinal Camera NM-STD 510 (k) number: K221329 Regulatory Class: II Product Code:… | 2023 |
| * | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleSummary page 6…K251353 PHELCOM TECHNOLOGIES Traditional 510(k) Premarket Submission Eyer 2 510 (k) number: K180378 Regulatory Class: II Product Code:… | 2018 |
| † | K152869 | LipiView II Ocular Surface Interferometer | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K221329.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Eyer 2® is a portable fundus camera for use with the Samsung Galaxy S21, Galaxy S22, or Galaxy S23 smartphone to capture fundus images. It can be coupled to a front module for imaging of the surface of the eye and the surrounding areas, , including the meibomian glands.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251353: Eyer 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251353
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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