# K203264: MicroDose Injector

- Pathway: 510(k) (Traditional)
- Applicant: Medone Surgical, Inc.
- Decided: Apr 26, 2021 after 172 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K980069 (1998). 6 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K200325: Orbit Subretinal Delivery System, Orbit Biomedical (2020) Summary page 4.

## Most influential descendants
- K213467: EVA NEXUS Ophthalmic Surgical System (2022), 1 descendant of its own
- K250501: System Sophi (2025), 0 descendants of its own

## Indications for use
The MicroDose Injector is indicated for low volume ophthalmic injections into the subretinal space.

Source page: https://510kreport.com/device/K203264
Methodology: https://510kreport.com/methodology