# K252120: Fundus On Phone Non Mydriatic (FOP NM-10)

- Pathway: 510(k) (Traditional)
- Applicant: Remidio Innovative Solutions Private Limited
- Decided: Dec 12, 2025 after 158 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: 6 generations back to K003376 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221329: Eyer Retinal Camera NM-STD, Phelcom Technologies (2023) Summary page 5.
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module, Optomed OY (2018) Summary page 5.

## Indications for use
FOP NM-10 is an ophthalmic non-mydriatic digital camera using iPhone SE3 which captures images of the fundus of the human eye and surface as well as surrounding areas of the human eye.

Source page: https://510kreport.com/device/K252120
Methodology: https://510kreport.com/methodology