# K221329: Eyer Retinal Camera NM-STD

- Pathway: 510(k) (Traditional)
- Applicant: Phelcom Technologies
- Decided: Feb 22, 2023 after 292 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003376 (2001). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module, Optomed OY (2018) Summary page 4.

## Most influential descendants
- K251353: Eyer 2 (2026), 0 descendants of its own
- K252120: Fundus On Phone Non Mydriatic (FOP NM-10) (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K221329
Methodology: https://510kreport.com/methodology