510(k) · Cleared
ClearedEyer Retinal Camera NM-STD
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 Feb 22, 2023 as substantially equivalent to K180378 (Optomed OY, 2018) after a 292-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Feb 22, 2023
- Review
- 292 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003376 (2001). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK003376 Welch Allyn 11800 OpthalmoscopeWelch Allyn, Inc. · 2001
- 4 generations backK092056 Optomed Smartscope, Model M3-1 EY1Optomed OY · 2009
- 3 generations backK110986 Optomed Smartscope M5 EY3 and M5 ES1Optomed OY · 2011
- 2 generations backK132186 Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope…Optomed OY · 2013
- 1 generation backK180378 Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior…Optomed OY · 2018
- This deviceK221329 Eyer Retinal Camera NM-STDPhelcom Technologies · 2023
- Descendant · cites it directly · 0 of its ownK251353 Eyer 2Phelcom Technologies · 2026
- Descendant · cites it directly · 0 of its ownK252120 Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn, Inc. | 2001 | — |
| −4 | K092056 | Optomed Smartscope, Model M3-1 EY1 | Optomed OY | 2009 | — |
| −3 | 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 | — |
| −1 | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Optomed OY | 2018 | — |
| 0 (this device) | K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | 2023 | — |
| +1 | K251353 | Eyer 2 | Phelcom Technologies | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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 12.7 · 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 |
|---|---|---|---|
| * | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleSummary page 4…Module Optomed Aurora Anterior Module 510(k) number: K180378 Regulatory Class: II Product code:… | 2018 |
What descends from it? (2)
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K251353 (Phelcom Technologies, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K180378.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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® Retinal Camera model NM-STD is a medical non-mydriatic digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the fundus of the human eye, surface of the human eye and surrounding areas
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221329: Eyer Retinal Camera NM-STD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221329
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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